VIDEO CENTER

Supply Reliability

  • Video transcript

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    ONSCREEN TEXT

    Why the supply reliability and single manufacturing profile of PEDIARIX matters to your practice1,2

    References: 1. Prescribing Information for PEDIARIX. 2. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND (All audio is spoken by Dr. Friedland)

    GSK has been a proud supplier of PEDIARIX for over 20 years.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist.

     

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

     

    ONSCREEN TEXT

    Supply Reliability

    Schedule Flexibility

    Efficacy and Safety

    Customer Solutions

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Some of these attributes include schedule flexibility, the efficacy of PEDIARIX and its safety profile, and customer solutions, including cost-saving programs. In this video, we’ll look at the importance of supplier reliability to help keep your DTaP immunization routine from being disrupted.

     

    First, let’s take a look at the Indication for PEDIARIX.

     

    ONSCREEN TEXT

    Indication for PEDIARIX

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    ONSCREEN TEXT

    When was the last time you experienced a vaccine supply disruption, and how did it impact your immunization routine?

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    In your practice, when was the last time you experienced a vaccine supply disruption, and how did it impact your immunization routine? What happened, or what would you imagine would happen, if you experienced supply shortages or delays? How would that affect your day-to-day vaccination routine?

     

    Bearing those questions in mind, I’d like to explain the importance of a reliable vaccine supplier for your patients and your practice, particularly with pediatric DTaP-containing vaccines.

     

    ONSCREEN TEXT

    There have been 3 DTaP-containing vaccine shortages and 1 pediatric HepB shortage in the last 12 years1,2*

    2012 – 2024

    Shortage 1: Non-GSK combination DTaP vaccine April 2012-July 2014 (820 days)2

    Shortage 2: Non-GSK DTaP-containing vaccine April 2012 – July 2014 (820 days)2

    Shortage 3: Non-GSK combination DTaP vaccine December 2015 – December 2016 (365 days)2

    Shortage 4: Non-GSK pediatric HepB vaccine August 2017 - March 2020 (940 days)2

     

    References: 1. CBER-regulated products: resolved shortages. US Food & Drug Administration website.
    https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351943.htm. Updated November 2024. Accessed December 3, 2024. 2. CBER-regulated products: resolved shortages. US Food & Drug Administration. Updated August 12, 2020. Accessed December 3, 2024.
    https://wayback.archiveit.org/7993/20201222144346/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages

     

    *Data as of December 2024. Shortages of vaccines were identified by the Center for Biologics

    Evaluation and Research (CBER) within the Food and Drug Administration. CBER works closely with the manufacturer to voluntarily obtain accurate information.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Let’s first take a look at the recent history of DTaP-containing vaccine shortages in the U.S., and one global pediatric hepatitis B vaccine shortage. In the last 12 years, there have been 3 DTaP containing vaccine shortages, ranging in duration from 365 days to 820 days.

     

    The first and longest DTaP shortage, a combination DTaP vaccine, began in April 2012 and was resolved July 2014.

     

    In this same time period, there was also a shortage of a non-combination, regular DTaP vaccine.

     

    The next DTaP shortage involved a combination DTaP vaccine. It began December 2015 and was resolved December 2016.

     

    In addition, a pediatric hepatitis B vaccine shortage, which began in August 2017, was not resolved until March of 2020.

     

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Now, take a moment to think about how even one of these shortages could have affected your practice or your patients. For example, what’s it like when you have to tell parents that you don’t have the vaccines needed to help protect their baby? How does it affect your staff when you give monovalent vaccines because the DTaP-containing combination vaccine that you use is out of stock?

     

    Let’s look at GSK and PEDIARIX in the context of these DTaP-containing vaccine shortages.

     

    ONSCREEN TEXT

    There have been 3 DTaP-containing vaccine shortages and 1 pediatric HepB shortage in the last 12 years1,2*

    2012 – 2024

    None of the 4 shortages included GSK’s DTaP- or pediatric HepB-containing vaccines.1,3

     

    References: 1. CBER-regulated products: resolved shortages. US Food & Drug Administration website.
    https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351943.htm. Updated November 2024. Accessed December 3, 2024. 2. CBER-regulated products: resolved shortages. US Food & Drug Administration. Updated August 12, 2020. Accessed December 3, 2024.
    https://wayback.archiveit.org/7993/20201222144346/https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-regulated-products-resolved-shortages 3. Data on file, GSK.

     

    *Data as of December 2024. Shortages of vaccines were identified by the Center for Biologics

    Evaluation and Research (CBER) within the Food and Drug Administration. CBER works closely with the manufacturer to voluntarily obtain accurate information.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    It’s important to note that out of those 3 DTaP-containing vaccine shortages and 1 pediatric hepatitis B vaccine shortage that occurred, none involved a GSK vaccine. In fact, GSK has a history of helping health care professionals avoid disruption in their DTaP and HepB immunization routines by helping provide the US market with additional doses in times of DTaP shortages.

     

    ONSCREEN TEXT

    During these DTaP-containing vaccine shortages and the global pediatric HepB shortage, GSK supplied millions of additional doses to help reduce impact1

    Reference: 1. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    During these DTaP-containing vaccine shortages and hepatitis B vaccine shortage, GSK responded by supplying millions of additional doses, specifically to help reduce the impact of market shortages.

     

    ONSCREEN TEXT

    Complete the Primary DTaP Series with PEDIARIX1,2

    [Chart showing vaccine needs and PEDIARIX coverage for first 6 months]

     

    DTaP=diphtheria, tetanus, and acellular pertussis. IPV=inactivated poliovirus vaccine.

    References: 1. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html?CDC_AAref_Val=https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html. Updated November 21, 2024. Accessed December 3, 2024. 2. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Let’s look at how these shortages could affect your DTaP immunization routine. The pediatric primary series calls for administration of appropriate DTaP-containing vaccines at 2, 4, and 6 months of age, so a DTaP shortage can be disruptive to completing this series in a timely manner. If vaccines are in short supply or not available, timing of subsequent vaccinations may be affected.

     

    ONSCREEN TEXT

    GSK is the sole manufacturer of PEDIARIX1:

    Reference 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Something else to consider regarding vaccine shortages is manufacturing.

     

    ONSCREEN TEXT

    GSK is the sole manufacturer of PEDIARIX1:

    [Image of factory] Single manufacturer

    HELPS ENSURE INTEGRATION OF ANTIGEN SUPPLY

    Reference 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    All antigenic components of GSK DTaP-containing vaccines come from the same manufacturer—GSK. This helps ensure integration of our antigen supply, allowing the flexibility to respond to DTaP needs.

     

    ONSCREEN TEXT

    PEDIARIX has never had a vaccine shortage in its over 20-year history1,2

    Reference 1. Prescribing Information for PEDIARIX. 2. Data on file, GSK.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    PEDIARIX was the first combination DTaP vaccine on the market, and in its over 20-year history has never had a vaccine shortage.

     

    ONSCREEN TEXT

    Maximum discounts: cost-saving programs with optimized group pricing and multiple contract options

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    Beyond supply reliability, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

     

    ONSCREEN TEXT

    Thank you for partnering with GSK and PEDIARIX

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    We hope this video provided you a better understanding of how GSK has supported your practice as a reliable supplier of PEDIARIX. Thank you for partnering with GSK. We look forward to supplying the vaccines you need to help your patients and your practice.

     

    ONSCREEN TEXT

    Avoid disruption of your DTaP immunization schedule—think PEDIARIX

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program.

    For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo

     

    DR. LEN FRIEDLAND

    You can order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com or by contacting your GSK Sales Representative.

     

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information available at PEDIARIX.com.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX

     

    • Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

    • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines

    • The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Important Safety Information for PEDIARIX.

     

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

     

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

     

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton

    • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

    • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.

     

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

    • In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite

    • Vaccination with PEDIARIX may not result in protection in all vaccine recipients

     

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2024 GSK or licensor.

    PMUS-PDRVID240003 December 2024

    Produced in USA.

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

     

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

     

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.

Portfolio

  • Video transcript

    ONSCREEN TEXT

    How PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX fit your immunization schedule

     

    DTaP=diphtheria, tetanus, and acellular pertussis.

     

    [Footer super for entire video: Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.]

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)]

    [INFANRIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)]

    [KINRIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)]

    [HIBERIX logo (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))]

     

    DR. LEN FRIEDLAND

    How PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX fit your immunization schedule.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    DR. LEN FRIEDLAND

    Hi, I’m Len Friedland, and I’m the Vice President and Director of Scientific Affairs and Public Health for Vaccines at GSK. I’m a practicing pediatrician, fellowship-trained in pediatric emergency medicine, and a vaccine research scientist.

     

    ONSCREEN TEXT

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)]

     

    DR. LEN FRIEDLAND

    Welcome to the eLecture series for PEDIARIX – a pediatric vaccine indicated for active immunization against 5 diseases.

     

    ONSCREEN TEXT

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)]

    [INFANRIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)]

    [KINRIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)]

    [HIBERIX logo (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))]

     

    DR. LEN FRIEDLAND

    In this video I’ll discuss how PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX can be used to help maintain your vaccination routine by fitting into your pediatric vaccination schedule.

    In this video, I’ll go over the Indications, dosing, and Important Safety Information for these products.

     

    ONSCREEN TEXT

    Indication for PEDIARIX

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

    The recommended dosing schedule for immunization with PEDIARIX consists of 3 doses at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks).1

    Reference: 1. Prescribing Information for PEDIARIX.

     

    [Global graphics from this point forward to closing scenes: PEDIARIX, INFANRIX, KINRIX and HIBERIX logos appear on the bottom right of the screen.]

     

    DR. LEN FRIEDLAND

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

    The recommended dosing schedule for immunization with PEDIARIX consists of 3 doses at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks).

     

    ONSCREEN TEXT

    Indication for INFANRIX

    INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 6 years of age (prior to the seventh birthday).

    Dosing schedule: The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age.1

    Reference: 1. Prescribing Information for INFANRIX.

     

    DR. LEN FRIEDLAND

    INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children 6 weeks to 6 years of age (prior to the seventh birthday).

    Dosing schedule: The series consists of a primary immunization course of 3 doses administered at 2, 4, and 6 months of age (at intervals of 4 to 8 weeks), followed by 2 booster doses, administered at 15 to 20 months of age and at 4 to 6 years of age.

     

    ONSCREEN TEXT

    Indication for KINRIX

    A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

     

    DR. LEN FRIEDLAND

    A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

     

    ONSCREEN TEXT

    Indication for HIBERIX

    HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to the fifth birthday).

     

    DR. LEN FRIEDLAND

    HIBERIX is indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to the fifth birthday).

     

    ONSCREEN TEXT

    How do the vaccines you use fit into your pediatric vaccination schedule?

     

    DR. LEN FRIEDLAND

    Before we start, let’s discuss your Hib and DTaP vaccination routine, from purchasing to administration. Specifically, think about how the vaccines you use fit into your pediatric vaccination schedule. What challenges or conflicts have come up in the past? With this in mind, I’d like to show you how the GSK family of DTaP-containing vaccines and HIBERIX fit your schedule and can help you maintain a consistent vaccination routine. Let’s take a look.

     

    ONSCREEN TEXT

    Help Protect Your Pediatric Patients1-4

    [Chart showing disease and vaccine coverage for Pediarix, Infanrix, Kinrix and Hiberix for Diptheria, Tetanus, Pertussis, Polio, Hepatitis B and Haemophilus influenzae type b]

    References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX. 3. Prescribing Information for KINRIX. 4. Prescribing Information for HIBERIX.

     

    DR. LEN FRIEDLAND

    For your infant patients, GSK offers a suite of vaccines that help protect against 6 diseases.

    PEDIARIX, the foundation of the GSK DTaP-containing vaccine family, helps protect against diphtheria, tetanus, and pertussis, as well as polio and hepatitis B. PEDIARIX also has the broadest age indication of any combination DTaP vaccine, 6 months through 6 years of age (prior to the 7th birthday).

    As DTaP booster doses, INFANRIX and KINRIX help protect against diphtheria, tetanus, and pertussis, with KINRIX providing additional protection against polio.

    And to help protect against Haemophilus influenzae type b, GSK offers HIBERIX.

     

    ONSCREEN TEXT

    HepB, DTaP, IPV, and Hib: From Birth Through 6 Years of Age1-4,*,†

    [Chart showing Vaccine recommendation by Age for HepB, DTaP, Polio (IPV) and Hib from Birth through 4-6 years]

    *Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

    †GSK’s DTaP-containing vaccines are to be administered according to their approved indications.

    References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX. 3. Prescribing Information for KINRIX. 4. Prescribing Information for HIBERIX.

     

    DR. LEN FRIEDLAND

    Both PEDIARIX and HIBERIX are indicated at 2, 4, and 6 months of age and are administered concomitantly. These 3 doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, poliomyelitis, and completes the course for vaccination against HepB. INFANRIX should be administered at 15-18 months old as a DTaP booster, with HIBERIX administered concomitantly as a final 4th dose. Administered at 4 through 6 years, KINRIX completes the pediatric vaccination series for DTaP and polio.

     

    ONSCREEN TEXT

    [Chart showing GSK Pediatric Vaccine1-5 and Schedule Fit6 for Pediarix, Infanrix, Kinrix, and Hiberix]

    References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX. 3. Prescribing Information for KINRIX. 4. Prescribing Information for HIBERIX. 5. Timing and spacing of immunobiologics. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html. Updated August 1, 2023. Accessed December 5, 2024. 6. Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2020 Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html. Updated November 21, 2024. Accessed December 5, 2024.

     

    DR. LEN FRIEDLAND

    In summary, PEDIARIX satisfies all primary DTaP and IPV immunizations and completes the hepatitis B series. INFANRIX satisfies the first DTaP booster requirement. KINRIX fits the second DTaP booster requirement and the IPV booster requirement. As a monovalent Hib vaccine, HIBERIX allows for dosing flexibility that may better accommodate CDC guidance for catch-up than a combination DTaP/Hib vaccine. Together, these vaccines complete your pediatric vaccination schedule for diphtheria, tetanus, pertussis, polio, hepatitis B, and Hib.

     

    The CDC prefers that vaccines doses in a DTaP series come from the same manufacturer, when possible. GSK is the sole manufacturer of all of the antigens in PEDIARIX–and a single antigen source helps ensure integration of antigen supply and flexibility to respond to your DTaP needs. With the GSK DTaP portfolio, patients can start and stay with the same DTaP antigen content as early as 6 weeks of age, up until their seventh birthday.

     

    ONSCREEN TEXT

    Premium Partner Program Contract Benefits: flexible ordering, free shipping, overnight delivery

     

    DR. LEN FRIEDLAND

    When you maintain the continuity of your schedule with the GSK pediatric vaccine portfolio, you can save on your vaccines purchases. Our Premium Partner Program gives you maximum portfolio discounts, GSK’s best pricing and other contract benefits, including flexible ordering with free shipping and overnight delivery. And you’ll get the same dependable customer service you count on with GSK.

     

    Contact your GSK Representative to learn more.

     

    ONSCREEN TEXT

    Thank you for partnering with GSK and PEDIARIX

    >100 million doses distributed in the US since 20031,2

    References: 1. Prescribing Information for PEDIARIX. 2. Data on file, GSK.

     

    DR. LEN FRIEDLAND

    I’d like to conclude by thanking you for partnering with GSK and PEDIARIX—the cornerstone of GSK’s DTaP-containing vaccine portfolio. GSK has delivered more than 100 million PEDIARIX doses in the United States since 2003, and is committed to continue helping your patients and your practice.

     

    ONSCREEN TEXT

    Help maintain a steady pediatric vaccination routine with PEDIARIX, GSK’s other DTaP-containing vaccines, and HIBERIX.

    Order PEDIARIX today:

    Call 1-866-475-8222

    Visit GSKDirect.com or contact your GSK sales representative

     

    Schedule a GSK Vaccines Business Review today to find out more about our Premium Partner Program

    For more information about PEDIARIX, INFANRIX, KINRIX, and HIBERIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    DR. LEN FRIEDLAND

    Do you know about our Premium Partner Program? You can schedule a GSK Vaccines Business Review today to find out more. Thank you for watching this video. For more information about PEDIARIX, INFANRIX, KINRIX, and HIBERIX, please see the Important Safety Information and full Prescribing Information for these products at PEDIARIX.com.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX, INFANRIX, and KINRIX

    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX
    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
    • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

     

    DR. LEN FRIEDLAND

    Do not administer PEDIARIX, INFANRIX, or KINRIX to anyone with severe allergic reactions to any component of the vaccine. Additional contraindications for PEDIARIX, INFANRIX, or KINRIX include: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX, INFANRIX, and KINRIX (cont’d)

    • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.
    • The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of a prior vaccine containing tetanus toxoid or if adverse reactions (ie, temperature ≥105◦F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.
    • The tip cap of the prefilled syringe may or may not be made from natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.
    • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    DR. LEN FRIEDLAND

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines. The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of a prior vaccine containing tetanus toxoid or if adverse reactions (ie, temperature ≥105◦F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

    The tip cap of the prefilled syringe may or may not be made from natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton. Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX, INFANRIX, and KINRIX (cont’d)

    • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX.
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX or INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
    • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite.
    • Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients.

     

    DR. LEN FRIEDLAND

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX. Apnea following intramuscular vaccination has been observed in some infants born prematurely. Carefully consider each infant’s medical status before proceeding with vaccine administration.

    In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were pain, redness, and swelling at the injection site, fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever, and loss of appetite. Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients.

     

    ONSCREEN TEXT

    Important Safety Information for HIBERIX

    • Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX
    • If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks
    • Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movement. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

     

    DR. LEN FRIEDLAND

    Contraindications for HIBERIX: severe allergic reaction (eg, anaphylaxis) after a previous dose of any H. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of HIBERIX. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including HIBERIX, should be based on careful consideration of the potential benefits and possible risks. Syncope (fainting) can occur in association with administration of injectable vaccines, including HIBERIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movement. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    ONSCREEN TEXT

    Important Safety Information for HIBERIX (cont’d)

    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
    • Prior to administration, the healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must
    • be immediately available should an acute anaphylactic reaction occur
    • Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained

     

    DR. LEN FRIEDLAND

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including HIBERIX, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. Prior to administration, the healthcare provider should review the patient’s immunization history for possible vaccine hypersensitivity. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur. Safety and effectiveness of HIBERIX in immunosuppressed children have not been evaluated. If HIBERIX is administered to immunosuppressed children, including children receiving immunosuppressive therapy, the expected immune response may not be obtained.

     

    ONSCREEN TEXT

    Important Safety Information for HIBERIX (cont’d)

    • Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX
    • Immunization with HIBERIX does not substitute for routine tetanus immunization
    • Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness,
    • fever, loss of appetite, sleepiness, fussiness, and restlessness
    • Vaccination with HIBERIX may not result in protection in all vaccine recipients

     

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2024 GSK or licensor

    PMUS-PDRVID240002 December 2024

    Produced in USA.

     

    DR. LEN FRIEDLAND

    Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receipt of an H. influenzae type b-containing vaccine, including HIBERIX. Immunization with HIBERIX does not substitute for routine tetanus immunization. Common solicited adverse reactions (≥20%) were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, sleepiness, fussiness, and restlessness. Vaccination with HIBERIX may not result in protection in all vaccine recipients.

Schedule Flexibility

  • Video transcript

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    ONSCREEN TEXT

    How a broad age indication and flexibility to catch up appropriate patients can benefit your practice and patients

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    How a broad age indication and flexibility to catch up appropriate patients can benefit your practice and patients.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. Welcome to the eLecture series for PEDIARIX.

     

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and other GSK DTaP-containing vaccines for your appropriate patients.

     

    ONSCREEN TEXT

    Supply Reliability

    Schedule Flexibility

    Efficacy and Safety

    Customer Solutions

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Some of these attributes include supply reliability, the efficacy of Pediarix and its safety profile, and customer solutions, including cost-saving programs. In this video, we’ll look at the dosing window of Pediarix in comparison with the other primary series combination DTaP vaccines and we’ll see how it might help your practice and patients.

     

    First, let’s take a look at the Indication for PEDIARIX.

     

    ONSCREEN TEXT

    Indication for PEDIARIX

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    ONSCREEN TEXT

    Complete the Primary DTaP Series with PEDIARIX1,2

    [Chart showing vaccine needs and PEDIARIX coverage for birth to 6 months]

     

    DTaP=diphtheria, tetanus, and acellular pertussis.

    IPV=inactivated poliovirus vaccine.

    References: 1. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. Updated November 21, 2024. Accessed November 26, 2024. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf 2. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Now let’s go over the recommended way you can use PEDIARIX in your practice.

     

    PEDIARIX can be administered as early as 6 weeks of age, with the last dose given prior to the patient’s seventh birthday. For the primary vaccination series, PEDIARIX should be administered as an intramuscular injection at 2, 4, and 6 months of age.

     

    These three doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and the complete course for vaccination against hepatitis B. PEDIARIX is dosed at intervals of 6 to 8 weeks, preferably 8 weeks. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

     

    ONSCREEN TEXT

    PEDIARIX can be administered as early as 6 weeks of age1

    at intervals of 6 to 8 weeks (preferably 8 weeks) up to 7th Birthday

    Reference 1. Prescribing information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    PEDIARIX has the broadest age indication of all primary series combination DTaP vaccines—as early as 6 weeks of age, at intervals of 6 to 8 weeks, preferably 8 weeks, up until the seventh birthday.

     

    ONSCREEN TEXT

    Chart showing PEDIARIX1, Pentacel2 and Vaxelis3 effectiveness for 6 weeks, 5th birthday and 7th birthday

    Reference 1. Prescribing information for PEDIARIX. 2. Prescribing information for Pentacel. 3. Prescribing information for Vaxelis.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    The other primary series combination DTaP vaccines are indicated until the fifth birthday. Therefore, PEDIARIX gives you flexibility to catch up those appropriate patients who fell behind schedule.

     

    ONSCREEN TEXT

    Have you ever encountered a situation where a patient was behind on shots?

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Let’s think about how these two extra years of dosing could potentially help your patients and your practice. Have you ever encountered a situation where a patient was behind on shots?

     

    ONSCREEN

    [image of open refrigerator with boxes of PEDIARIX, the boxes then disappear]

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Even if you haven’t, take a moment to imagine you need to catch up an older patient, 5 or 6 years old, without having a combination DTaP vaccine indicated for that age in your fridge.

     

    ONSCREEN

    [image of 4 syringe icons and a crying baby icon animate onscreen.]

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    How do you think a 5-year-old patient would react to getting 3 or 4 shots at each visit?

    In these situations, two more years of dosing ability with PEDIARIX can be helpful. Let’s illustrate this with an example.

     

    ONSCREEN TEXT

    Catching up with PEDIARIX

    Patient: Preston

    Age: 5 years and 1 month

    Immunizations: HepB birth dose

    Goal: To have him caught up with DTaP, HepB, and IPV within 3 administrations

    With PEDIARIX, Preston can be caught up with 3 administrations1

    Reference 1. Prescribing information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Preston, who’s 5 years and 1 month old, is a patient whose vaccinations are delayed: apart from his HepB birth dose, he hasn’t received any vaccinations since.

     

    To get him caught up to the primary series for DTaP and IPV, and the full 3-dose series of Hepatitis B, he will receive his first dose of PEDIARIX at this visit, the second dose two months later, and his third and final dose two months after that. So with just three administrations of PEDIARIX, he will complete the primary series for DTaP and IPV, and the 3-dose series for Hepatitis B.

     

    ONSCREEN TEXT

    PEDIARIX gives you flexibility to catch up those appropriate patients who fall behind schedule, up until the seventh birthday1

    Reference 1. Prescribing information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    You may be wondering why PEDIARIX has 2 more dosing years than the other combination DTaP vaccines. The answer lies in the antigens that are in PEDIARIX. All the PEDIARIX antigens, including HepB, have dosing windows that go up to the seventh birthday. In contrast, the Hib component found in the other combination DTaP vaccines is approved only until the fifth birthday, which restricts the dosing window to then.

     

    Pediarix gives you flexibility to catch up those appropriate patients who fall behind schedule, up until the seventh birthday. Using a monovalent Hib vaccine with PEDIARIX gives you two more combination DTaP dosing years, when appropriate.

     

    ONSCREEN TEXT

    Maximum discounts: cost-savings programs with optimized group pricing and multiple contract options

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Beyond schedule flexibility, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

     

    ONSCREEN TEXT

    Thank you for partnering with GSK and PEDIARIX

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    After watching this video, I hope you have a better understanding of the schedule flexibility PEDIARIX provides.

     

    Thank you for partnering with GSK. We look forward to supplying the vaccines you need to help your patients and your practice.

     

    ONSCREEN TEXT

    Choose PEDIARIX: a flexible 5-in-1 vaccine used to help maintain your immunization routine.1

    Order PEDIARIX today: Call 1-866-475-8222

    Visit GSKDirect.com or contact your GSK Sales Representative

     

    Schedule a GSK Vaccines Business Review today to find out more about our Premium Partner program.

     

    For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    Reference: 1. Prescribing information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Keep your practice’s well-established DTaP immunization routine running smoothly. Order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

     

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX

     

    • Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria  toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

    • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines

    • The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Important Safety Information for PEDIARIX.

     

    Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria  toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

     

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

     

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton

    • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

    • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.

     

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX (cont’d)

     

    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

    • In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite

    • Vaccination with PEDIARIX may not result in protection in all vaccine recipients

     

    Pentacel is owned by Sanofi Pasteur.

    Vaxelis is owned by the MSP Vaccine Company.

    All other trademarks are owned by or licensed to the GSK group of companies.

    ©2024 GSK or licensor.

    PMUS-PDRVID240004 November 2024

    Produced in USA.

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

     

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

     

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.

Efficacy and Safety

  • Video transcript

    ONSCREEN TEXT

    Vaccinating Against Pertussis in Your Community.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    DR. LEN FRIEDLAND

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. In this chapterized video, I will discuss the incidence of and disease background for pertussis. Then, I’ll review how to help protect appropriate patients against pertussis in your community.

     

    ONSCREEN TEXT

    Why Is It Important to Vaccinate Appropriate Patients Against Pertussis?

     

    ONSCREEN TEXT

    Have you heard about cases of pertussis in your community?

     

    DR. LEN FRIEDLAND

    Let’s begin by reflecting on the potential impact of pertussis. Have you heard about cases of pertussis in your community?

     

    ONSCREEN TEXT and DR LEN FRIEDLAND

    What would you imagine has been the impact of pertussis on patients, their families, and medical practices?

     

    ONSCREEN TEXT

    CDC= Centers for Disease Control and Prevention

     

    DR. LEN FRIEDLAND

    Considering these questions, let’s explore what pertussis is and why it is of concern to public health agencies such as the CDC, and to the healthcare community.

     

    ONSCREEN TEXT

    What is Pertussis?1

    Also known as “whooping cough”

    Acute respiratory infectious disease

    Caused by Bordetella pertussis

    Bursts of numerous, rapid coughs

    Characteristic high-pitched whop

    Infants <6 months may not have the strength to have a whoop

    References: 1. Epidemiology and prevention of vaccine-preventable diseases. Pertussis. Centers for Disease Control and Prevention website. https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-16-pertussis.html. Updated April 12, 2024. Accessed December 5, 2024.

     

    DR. LEN FRIEDLAND

    Pertussis—also known as whooping cough—is an acute infectious disease of the respiratory tract caused by the bacterium Bordetella pertussis. Characteristically, during the paroxysmal phase the patient has bursts, or paroxysms, of numerous, rapid coughs followed by an inspiratory effort that is usually accompanied by a high-pitched whoop.

     

    An infant with whooping cough may sound like this: [Audio plays of infant coughing]

     

    However, infants younger than 6 months may lack the respiratory strength to produce a whoop, and cough may be minimal or absent.

     

    ONSCREEN TEXT

    Pertussis1 may persist up to

    10 weeks “100-day cough”

    Influenza2

    3-7 days

    References: 1. Symptoms of Whooping Cough (Pertussis). Centers for Disease Control and Prevention website. https://www.cdc.gov/pertussis/signs-symptoms/. Updated April 2, 2024. Accessed December 5, 2024. 2. Clinical signs and symptoms of Influenza. Centers for Disease Control and Prevention website. https://www.cdc.gov/flu/clinical-signs/. Updated August 8, 2024. Accessed December 5, 2024.

     

    DR. LEN FRIEDLAND

    These coughing fits usually last 1 to 6 weeks, but may persist up to 10 weeks or more.

    So, some people know this disease as the “100-day cough.”

     

    To put this length of time in perspective, signs and symptoms of uncomplicated flu typically resolve after 3 to 7 days for the majority of people.

     

    ONSCREEN TEXT

    Highly communicable1

    80% secondary attack rate*

    *Frequency of new cases of pertussis among close contacts of known patients

    Reference: 1. Epidemiology and prevention of vaccine-preventable diseases. Pertussis. Centers for Disease Control and Prevention.
    https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-16-pertussis.html
    Updated April 12, 2024. Accessed December 5, 2024.

     

    DR. LEN FRIEDLAND

    And, pertussis is highly communicable, as evidenced by secondary attack rates of up to 80 percent among susceptible household contacts. Note that the secondary attack rate represents the spread of disease from the initial case to close contacts within a household or family.

     

    DR. LEN FRIEDLAND

    The seriousness of pertussis, including persistent coughing fits for a lengthy period of time and high communicability, make it important to vaccinate against this disease.

     

    ONSCREEN TEXT

    Pertussis is a serious, highly contagious disease which is active in the United States.1,2

    Reference: 1. Epidemiology and prevention of vaccine-preventable diseases. Pertussis. Centers for Disease Control and Prevention.
    https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-16-pertussis.html
    Updated April 12, 2024. Accessed December 5, 2024. 2. Centers for Disease Control and Prevention. 2024 Provisional pertussis surveillance report. https://www.cdc.gov/pertussis/media/pdfs/2025/01/pertuss-surv-report-2024_PROVISIONAL-508.pdf. Updated January 2025. Accessed January 20, 2025.

     

    DR. LEN FRIEDLAND

    Pertussis is a serious, highly contagious disease which is active in the United States.

     

    ONSCREEN TEXT

    [map of the United States]

    35,4351

    Pertussis cases in the United States, Provisional, 2024*

    10.6 incidence per 100,000 people

    *Note: Cases include individuals who range from <6 months of age to 20 years of age and older, including unknown ages. Total incidence per 100,000 was calculated from 35,427 cases with age reported. Surveillance data have limitations and are often incomplete. In 2024, 61.7% of pertussis cases among children 6 months to 6 years of age had unknown pertussis vaccination history (provisional). These data cannot be used to interpret vaccine effectiveness or to assess risk, as the data are incomplete and there is no healthy comparison group.

    Reference: 1. Centers for Disease Control and Prevention. 2024 Provisional pertussis surveillance report. https://www.cdc.gov/pertussis/media/pdfs/2025/01/pertuss-surv-report-2024_PROVISIONAL-508.pdf. Updated January 2025. Accessed January 20, 2025.

     

    DR. LEN FRIEDLAND

    Here you can see the cases of pertussis that were reported in the U.S. in 2024, as well as the incidence per 100,000 people. These cases are from the CDC's 2024 provisional pertussis surveillance report. Please note surveillance data have limitations, and are often incomplete. In 2024, 61.7% of pertussis cases among children 6 months to 6 years of age had unknown pertussis vaccination history (provisional). These data cannot be used to interpret vaccine effectiveness or to assess risk, as the data are incomplete and there is no healthy comparison group.

     

    Let’s now move on to our next chapter, which focuses on vaccination of appropriate patients against pertussis.

     

    ONSCREEN TEXT

    How Can Demonstrated Safety and Efficacy Against Pertussis Help Your Appropriate Patients and Practice?

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine) [GSK logo]

     

    DR. LEN FRIEDLAND

    Now that we’ve reviewed some background information about pertussis, let’s delve into PEDIARIX and the other GSK DTaP-containing vaccines, beginning with the Indications.

     

    ONSCREEN TEXT

    Indications for PEDIARIX, INFANRIX, and KINRIX

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to the seventh birthday).

     

    A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)

    [Kinrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years of age (prior to the seventh birthday). A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis vaccine series and the fourth dose in the inactivated poliovirus vaccine series in children aged 4 through 6 years (prior to the seventh birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX, INFANRIX, or KINRIX

    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine or to any component of PEDIARIX is a contraindication for PEDIARIX
    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine or to any component of INFANRIX is a contraindication for INFANRIX
    • Severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, or poliovirus-containing vaccine or to any component of KINRIX, including neomycin and polymyxin B, is a contraindication for KINRIX
    • Additional contraindications for PEDIARIX, INFANRIX, and KINRIX are: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)

    [Kinrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Do not administer PEDIARIX, INFANRIX, or KINRIX to anyone with severe allergic reactions to any component of the vaccines. Additional contraindications for PEDIARIX, INFANRIX, or KINRIX include: encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; or progressive neurologic disorders.

     

    TEXT ONSCREEN

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    In this chapter, we will continue our series of videos that explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

     

    ONSCREEN TEXT

    Supply Reliability

    Efficacy and Safety

    Schedule Flexibility

    Customer Solutions

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Some of these benefits include supply reliability, schedule flexibility, and customer solutions, including cost-saving programs. Moving forward, we will examine how the demonstrated safety and efficacy of PEDIARIX against pertussis can help appropriate patients in your practice.

     

    ONSCREEN TEXT

    PEDIARIX Includes Antigens for DTaP, Hepatitis B, and Poliomyelitis1,2

    [Chart showing HepB vaccine at birth and DTaP and IPV vaccines with PEDIARIX coverage for 2, 4 and 6 months]

    DTaP = diphtheria, tetanus, and acellular pertussis; HepB = hepatitis B; IPV = inactivated poliovirus.

    References: 1. Prescribing Information for PEDIARIX. 2. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Updated November 21, 2024. Accessed December 5, 2024.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    PEDIARIX is a vaccine that includes antigens for diphtheria, tetanus, and pertussis (collectively known as DTaP); hepatitis B, and poliomyelitis. Please note that according to CDC, administration of 4 doses of hepatitis B vaccine is permitted when a combination vaccine containing HepB is used after the birth dose. So, PEDIARIX may indeed be used at 2, 4, and 6 months following a birth dose of hepatitis B.

     

    ONSCREEN TEXT

    The DTaP antigen content of PEDIARIX is identical to that of INFANRIX1,2

    [Chart on screen: Same as prior screen showing that the DTaP antigen content of PEDIARIX is identical to that of INFANRIX, by having the INFANRIX logo fade on screen.]

    DTaP = diphtheria, tetanus, and acellular pertussis; HepB = hepatitis B; IPV = inactivated poliovirus.

    References: 1. Prescribing Information for PEDIARIX. 2. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Updated November 21, 2024. Accessed December 5, 2024.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Note that the DTaP antigen content of PEDIARIX is identical to that of INFANRIX. We will cover why this is important to understanding the efficacy of PEDIARIX against pertussis later in this video.

     

    ONSCREEN TEXT

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Let’s examine the data that support…

     

    ONSCREEN TEXT

    Efficacy against pertussis1

    Safety profile of PEDIARIX1

    Reference: 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    …the demonstrated efficacy of PEDIARIX against pertussis, and the safety profile of PEDIARIX, which has been studied in 14 trials worldwide. Note that the efficacy of PEDIARIX is based on the immunogenicity of the individual antigens compared with licensed vaccines. Serological correlates of protection exist for the diphtheria, tetanus, hepatitis B, and poliovirus components. The efficacy of the pertussis component, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX.

     

    ONSCREEN TEXT

    Study Design:

    A prospective, double-blind, randomized, active DT-controlled trial of INFANRIX administered at 2, 4, and 6 months of age.1

    DT = Diphtheria tetanus

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    To begin, as I said, the efficacy of PEDIARIX against pertussis was determined through clinical studies of INFANRIX, which shares an identical DTaP antigen content. A double-blind, randomized, active Diphtheria - Tetanus controlled trial assessed the absolute protective efficacy of INFANRIX against pertussis when administered at 2, 4, and 6 months of age.

     

    ONSCREEN TEXT

    A 3-dose series of INFANRIX, the DTaP component of PEDIARIX, demonstrated efficacy against pertussis in infants1,2*

    [Bar chart: Efficacy of INFANRIX against pertussis

    Efficacy % (95% CI): 0-100% (Y-Axis)

    WHO-Defined Typical Pertussis ≥21 days†: 84% (76, 89)

    Milder Pertussis with any cough ≥14 days‡: 73% (63, 80)

    Milder Pertussis with any cough >7 days‡: 71% (60, 78)

    n=4481]

    References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX.

    CI=confidence interval

    *The mean length of follow-up was 17 months, beginning 30 days after the third dose of vaccine.

    †Typical pertussis, as defined by the World Health Organization (WHO), 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.

    ‡Clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Following completion of a 3-dose series, an 84 percent vaccine efficacy was observed against typical pertussis, defined as 21 days or more of paroxysmal cough with confirmed infection. When the definition of pertussis was expanded to include clinically milder disease, vaccine efficacy was 71 percent against any cough lasting longer than 7 days and 73 percent against any cough lasting at least 14 days.

     

    ONSCREEN TEXT

    A 3-dose series of INFANRIX, the DTaP component of PEDIARIX, demonstrated efficacy against pertussis in infants1,2*

    [super over chart from previous scene]

    Protection against pertussis was sustained to 6 years of age1,2

    Efficacy against typical pertussis†:

    86% (95% CI: 79,91)

    PEDIARIX is approved for use as a 3-dose primary series and by itself does not constitute a complete vaccination course for DTaP.

    References: 1. Prescribing Information for PEDIARIX. 2. Prescribing Information for INFANRIX.

    CI=confidence interval

    *The mean length of follow-up was 17 months, beginning 30 days after the third dose of vaccine.

    †Typical pertussis, as defined by the World Health Organization (WHO), 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.

    ‡Clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    In an extended, unblinded follow-up period among children 3 to 6 years, the efficacy of INFANRIX against typical pertussis was 86 percent. Thus, protection against pertussis in children administered 3 doses of INFANRIX in infancy was sustained to 6 years of age. Note that PEDIARIX is approved for use as a 3-dose primary series, and, by itself, does not constitute a complete vaccination course for DTaP.

     

    ONSCREEN TEXT

    In clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10% to 53%, depending on reaction and dose number, and were highest following doses 4 and 5

    Fever was common (20 % to 30 %) following doses 1-3

    Other common solicited adverse events reported in approx. 15% to 60% of subjects were:

    • Drowsiness
    • Irritability or fussiness
    • Loss of appetite


    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    With respect to clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10 percent to 53 percent, depending on reaction and dose number, and was highest following doses 4 and 5. Fever was common (20 percent to 30 percent) following doses 1 through 3. Other common solicited adverse events reported in approximately 15 percent to 60 percent of subjects were drowsiness, irritability or fussiness, and loss of appetite, depending on event and dose number.

     

    ONSCREEN TEXT

    Study Design:

    A prospective, controlled, household contact trial of INFANRIX assessed protective efficacy against WHO-defined pertussis1*

    *21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.

    WHO=World Health Organization

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    A prospective efficacy trial was also conducted in Germany and employed a household contact study design.

     

    ONSCREEN TEXT

    Study Design:

    3 doses of INFANRIX administered at 3, 4 and 5 months of age to >22,000 infants1

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    In preparation for this study, 3 doses of INFANRIX were administered at 3, 4, and 5 months of age to more than 22,000 infants.

     

    ONSCREEN TEXT

    Study Design: Household contacts of index cases monitored for pertussis1

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Index cases of pertussis were identified by spontaneous presentation to a physician.

    Households with at least one additional member besides the index case who was aged 6 months through 47 months were enrolled into the efficacy study.

    Household contacts of index cases were monitored for incidence of pertussis by a physician who was blinded to the vaccination status of the household.

     

    ONSCREEN TEXT

    Vaccine efficacy: based on attack rates of pertussis in household contacts classified by vaccination status

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Vaccine efficacy was calculated based on attack rates of pertussis in household contacts classified by vaccination status.

     

    ONSCREEN TEXT

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Let’s look at the results for World Health Organization-defined typical pertussis.

     

    ONSCREEN TEXT

    173 household contacts who had not received a pertussis vaccine

    96 developed WHO-defined pertussis*

    112 household contacts vaccinated with INFANRIX

    7 developed WHO-defined pertussis*

    *As defined by the World Health Organization, typical pertussis is 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Of the 173 household contacts who had not received a pertussis vaccine, 96 of these individuals developed WHO-defined pertussis, as compared with 7 of the 112 contacts vaccinated with INFANRIX.

     

    ONSCREEN TEXT

    Efficacy of INFANRIX Against Pertussis in a Household Contact Study (Following 3 Doses)

    [Bar chart: Protective Efficacy (%) (Y-Axis)

    WHO-Defined Pertussis: 89% (95% CI: 77, 95)

    Milder Pertussis with any cough ≥7 days†: 67% (95% CI: 52, 78)

    Milder Pertussis with paroxysmal cough ≥7 days†: 81% (95% CI: 68, 89)

    Reference: 1. Prescribing Information for INFANRIX.

    CI=confidence interval

    *As defined by the World Health Organization, typical pertussis is 21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing.

    †Clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    Therefore, the efficacy following a three-dose series of INFANRIX was calculated to be 89 percent.

    And, when the definition of pertussis was expanded to include clinically milder disease, the efficacy of INFANRIX was

    • 67 percent against 7 or more days of any cough
    • 81 percent against 7 or more days of paroxysmal cough

     

    ONSCREEN TEXT

    In clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10% to 53%, depending on reaction and dose number, and were highest following doses 4 and 5

    Fever was common (20% to 30%) following doses 1-3

    Other common solicited adverse events reported in approx. 15% to 60% of subjects were:

    Drowsiness, Irritability or fussiness, Loss of appetite

    Reference: 1. Prescribing Information for INFANRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

     

    DR. LEN FRIEDLAND

    As noted earlier, in clinical trials with INFANRIX, rates of injection-site reactions (pain, redness, swelling) ranged from 10 percent to 53 percent, depending on reaction and dose number, and were highest following doses 4 and 5. Fever was common (20 percent to 30 percent) following doses 1 through 3.

     

    ONSCREEN TEXT

    Important Safety Information for PEDIARIX, INFANRIX, and KINRIX (cont’d)

    • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
    • The decision to give PEDIARIX, INFANRIX, or KINRIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥ 105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine
    • The tip cap of the prefilled syringe for PEDIARIX, INFANRIX, and KINRIX may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
    • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral profusion following syncope
    • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX and INFANRIX should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
    • In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever and loss of appetite
    • Vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients

     

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)

    [Kinrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

     

    DR. LEN FRIEDLAND

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines. The benefits and risks of PEDIARIX, INFANRIX, or KINRIX should be carefully considered in anyone who experienced Guillain-Barré syndrome within 6 weeks of a prior vaccine containing tetanus toxoid, or if any of the adverse reactions that are listed in the second bullet on the screen have occurred after receipt of a pertussis-containing vaccine.

     

    The tip cap of the prefilled syringe for PEDIARIX, INFANRIX, and KINRIX may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral profusion following syncope.

     

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX, INFANRIX, or KINRIX.

     

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Carefully consider each infant’s medical status before proceeding with vaccine administration.

     

    In clinical trials of PEDIARIX and INFANRIX, common adverse reactions were injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite. In clinical trials of KINRIX, common adverse reactions were injection-site reactions (pain, redness, increase in arm circumference, and swelling), drowsiness, fever and loss of appetite.

     

    Remember, vaccination with PEDIARIX, INFANRIX, or KINRIX may not result in protection in all vaccine recipients.

     

    ONSCREEN TEXT

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    We understand that choosing a vaccine that has demonstrated efficacy and safety is important for you.

     

    ONSCREEN TEXT

    The safety profile of PEDIARIX

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    So, let’s look at the safety profile of PEDIARIX, which has been demonstrated in 14 safety trials worldwide.

     

    ONSCREEN TEXT

    The safety profile of PEDIARIX was demonstrated in 14 trials worldwide1

    23,849 doses of PEDIARIX administered to 8088 infants who received 1 or more doses

     

    Common solicited adverse events following any dose (≥25%) included local injection site reactions (pain, redness, and swelling), fever (≥100.4°F), drowsiness, irritability/fussiness, and loss of appetite.

     

    The safety profile was studied in clinical trials and reinforced in a postmarketing safety surveillance study1

    Reference: 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    There have been 23,849 doses of PEDIARIX administered to 8,088 infants during the 14 clinical studies. The most common solicited adverse events following any dose occurring at greater than 25 percent included local injection-site reactions, namely, pain, redness, and swelling; a fever with a temperature of 100.4°F or higher, drowsiness, irritability/fussiness, and a loss of appetite.

     

    ONSCREEN TEXT

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    In comparative studies, administration of PEDIARIX …

     

    ONSCREEN TEXT

    PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.1

    More than 96% of episodes of fever resolved within the 4-day period following vaccination

    Reference: 1. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    …was associated with higher rates of fever relative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination. More than 96 percent of episodes of fever resolved within the 4-day period following vaccination (that is, the period including the day of vaccination and the next 3 days).

     

    ONSCREEN TEXT

    When possible, the CDC prefers that vaccine doses in the DTaP series come from the same manufacturer.1,2

    CDC=Centers of Disease Control and Prevention

    Reference: 1. Timing and spacing of immunobiologics. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.html. Updated July 24, 2024. Accessed December 5, 2024. 2. Liang JL, Tiwari T, Moro P, et al. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2018;67(No. RR-2):1–44. DOI: http://dx.doi.org/10.15585/mmwr.rr6702a1

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Now that we’ve reviewed the efficacy and safety of PEDIARIX, let’s look at another important consideration regarding DTaP combination vaccines. When possible, the CDC prefers that vaccine doses in the DTaP series come from the same manufacturer.

     

    ONSCREEN TEXT

    CDC prefers that doses of DTaP vaccine in a series come from the same manufacturer1-3

    Example:

    [Chart for HepB, DTaP, and IPV From Birth Through 6 Years of Age3-6

    Birth: HepB Birth dose

    2 months: HepB, DTaP, & IPV: PEDIARIX

    4 months: HepB, DTaP, & IPV: PEDIARIX

    6 months: HepB, DTaP, & IPV: PEDIARIX

    15-18 months: DTaP: INFANRIX

    4-6 years: DTaP & IPV: KINRIX]

    CDC=Centers of Disease Control and Prevention

    Reference: 1. Timing and spacing of immunobiologics. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.html. Updated July 24, 2024. Accessed December 5, 2024. 2. Liang JL, Tiwari T, Moro P, et al. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2018;67(No. RR-2):1–44. DOI: http://dx.doi.org/10.15585/mmwr.rr6702a1 3. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Updated November 21, 2024. Accessed December 5, 2024. 4. Prescribing Information for PEDIARIX. 5. Prescribing Information for INFANRIX. 6. Prescribing Information for KINRIX.

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)

    [Kinrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    With the GSK DTaP vaccine portfolio, patients can start and stay with the same DTaP antigen as early as 6 weeks of age through 6 years of age, up until the 7th birthday.

    PEDIARIX is administered for all 3 doses of the primary series, INFANRIX is administered for the 4th dose, and KINRIX is administered for the 5th and final dose.

     

    ONSCREEN TEXT

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Beyond proven efficacy and demonstrated safety, PEDIARIX supports your practice in other practical ways…

     

    ONSCREEN TEXT

    Maximum discounts: cost-savings programs with optimized group pricing and multiple contracting options

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    …with cost-saving programs, such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

     

    ONSCREEN

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

    [Infanrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed)

    [Kinrix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccines Adsorbed and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    We hope this video gave you a deeper understanding of the science and safety supporting the use of PEDIARIX for appropriate patients. For more information about PEDIARIX, INFANRIX and KINRIX, please see the full Prescribing Information on www.PEDIARIX.com.

     

    ONSCREEN TEXT

    Thank you for partnering with GSK and PEDIARIX

     

    Please see Important Safety Information for PEDIARIX, INFANRIX, and KINRIX throughout this video, and full Prescribing Information for all three products at PEDIARIX.com.

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    Thank you for partnering with GSK and PEDIARIX. We look forward to supplying the vaccines you need for your patients and your practice.

     

    ONSCREEN TEXT

    Order PEDIARIX today:

    Call 1-866-475-8222

    Visit GSKDirect.com or contact your GSK Sales Representative

    Schedule a GSK Vaccines Business review today to find out more about our Preferred Partner Program.

    For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information at www.PEDIARIX.com.

     

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2025 GSK or licensor.

    PMUS-PDRVID240001 January 2025

    Produced in USA.

     

    [Pediarix logo] (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)

     

    DR. LEN FRIEDLAND

    You can order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

     

    For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

Nurses’ Guide to PEDIARIX

  • Video transcript

    ONSCREEN TEXT

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    ONSCREEN TEXT

    A Guide to Administration of PEDIARIX for Nurses

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    A guide to the administration of PEDIARIX for Nurses.

     

    ONSCREEN TEXT

    Dr. Leonard Friedland

    VP, Scientific Affairs & Public Health

    GSK Vaccines

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Hi. My name is Len Friedland, and I’m the Vice President for Scientific Affairs and Public Health for GSK Vaccines. I’m a practicing pediatrician, fellowship trained in pediatric emergency medicine and a vaccine research scientist. Welcome to the eLecture series for PEDIARIX.

     

    This series of videos will explore the clinical, financial, and organizational benefits of using PEDIARIX and the other GSK DTaP-containing vaccines for your appropriate patients.

     

    ONSCREEN TEXT

    Supply Reliability

    Schedule Flexibility

    Efficacy and Safety

    Customer Solutions

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Some of these attributes include supply reliability, schedule flexibility, the efficacy of PEDIARIX and its safety profile, and customer solutions, including cost-savings programs.

     

    ONSCREEN TEXT

    • Dosing
    • Administration
    • Storage
    • Barcodes and CPT Codes

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    In this video, we’ll cover dosing, administration, and storage, as well as barcodes and CPT codes to help you better manage your PEDIARIX supply and your immunization schedule.

     

    First, let’s take a look at the Indication for PEDIARIX.

     

    ONSCREEN TEXT

    Indication for PEDIARIX

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

     

    ONSCREEN TEXT

    GSK is here to provide solutions to help maintain the continuity of your well-established primary series DTaP immunization schedule.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    We know your practice gets busy, and maintaining the vaccination scheduling for your pediatric patients is a top priority. GSK is here to provide solutions to help maintain the continuity of your well-established primary series DTaP immunization schedule.

     

    ONSCREEN TEXT

    Continue your DTaP immunization routine without interruption with PEDIARIX

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    At GSK, we also understand how important it is to continue your DTaP immunization routine without interruption. As the cornerstone of GSK’s DTaP-containing vaccine portfolio since 2002, PEDIARIX is here to help maintain the continuity of your primary series DTaP immunization schedule.

     

    ONSCREEN TEXT

    Complete the Primary DTaP Series with PEDIARIX1,2

    [Chart showing vaccine needs and PEDIARIX coverage for first 6 months]

     

    DTaP=diphtheria, tetanus, and acellular pertussis.

    IPV=inactivated poliovirus vaccine.

    References: 1. Recommended immunization schedule for children and adolescents aged 18 years or younger 2025. Centers for Disease Control and Prevention website.
    https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Updated November 21,2024. Accessed November 26, 2024. 2. Prescribing Information for PEDIARIX.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    PEDIARIX can be administered as early as 6 weeks of age, with the last dose given prior to the patient’s seventh birthday. For the primary vaccination series, PEDIARIX should be administered as an intramuscular injection at 2, 4, and 6 months of age. These three doses of PEDIARIX make up the primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis, and completes the course of vaccination against hepatitis B.

     

    PEDIARIX is dosed at intervals of 6 to 8 weeks, preferably 8 weeks. Data are not available on the safety and effectiveness of using PEDIARIX following one or more doses of a DTaP vaccine from a different manufacturer.

     

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    Color-coded to help with identification.

    The tip cap of the prefilled syringes may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    PEDIARIX comes in a convenient 0.5-milliliter color-coded, single dose prefilled syringe. To help you reduce the steps in the administration process, the syringe is prefilled with a single-unit dose, and is color coded to help with identification. Please be aware that the tip caps of the prefilled syringes may or may not be made with natural rubber latex, which may cause allergic reactions. Please check the carton.

     

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    2D barcodes contain the:

    • National Drug Code (NDC) number
    • Lot number
    • Expiration date

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    To further help save you time and manage your vaccine supply, PEDIARIX has 2-D bar codes that contain the National Drug Code (or, NDC) number, lot number, and expiration date.

     

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    More easily update your:

    • Inventory management system
    • Patient records
    • Vaccination reports

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    With this additional information, you can more easily update your inventory management system, patient records, and vaccination reports through any compatible Electronic Medical Record or Electronic Health Record.

     

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    2D barcodes contain the National Drug Code (NDC) numbers, lot number, and expiration date

    • Syringe NDC: 58160-811-43
    • Outer Carton (Package of 10) NDC: 58160-811-52
    • CPT Code: 90723

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    For your convenience, all the information you need for charting is found on the carton, including the lot number, expiration date, UPC and 2-D bar codes, and the numbers for both the syringe and the outer carton. The CPT code for PEDIARIX is 90723.

     

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    Preparation and Administration

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    GSK wants to help simplify all aspects of the vaccination process for your practice, which is why we’ve designed our vaccine packaging with you in mind. Now that we’ve talked about the packaging, let’s go over the administration process for PEDIARIX.

     

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    Shake vigorously to get a homogenous, white suspension

    Children <1: anterolateral aspect of thigh

    Older Children: deltoid muscle

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Shake PEDIARIX vigorously to obtain a homogenous, turbid, white suspension. Once mixed, attach a sterile needle to the syringe and administer the dose of PEDIARIX intramuscularly.

    For children younger than 1 year of age, the preferred administration site is the anterolateral aspect of the thigh. In older children, the deltoid muscle is usually large enough for an intramuscular injection. PEDIARIX should not be injected in the gluteal area or in areas where there may be a major nerve.

     

    Do not administer PEDIARIX intravenously, intradermally, or subcutaneously.

     

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    Refrigerate between 2° and 8°C (36° and 46°F)

    Do not freeze.

    Discard if the vaccine has been frozen.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    When storing your PEDIARIX supply, be sure to refrigerate between 2 and 8 degrees Celsius, that is, between 36 and 46 degrees Fahrenheit. If the vaccine has been frozen, do not use it, and be sure to dispose of it properly.

     

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    Maximum discounts:

    Cost savings programs with optimized group pricing and multiple contract options

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Beyond supply, PEDIARIX supports your practice in other practical ways, with cost-savings programs such as optimized group pricing and multiple contract options. Contact your GSK Representative to learn more.

     

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    Thank you for partnering with GSK and PEDIARIX

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    We hope this video provided you with a better understanding of the dosing, administration, packaging, and storage of PEDIARIX.

     

    Thank you for partnering with GSK and PEDIARIX. We look forward to supplying the vaccines you need to help your patients and your practice.

     

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    Continue your DTaP immunization routine without interruption with PEDIARIX.

     

    Order PEDIARIX today: Call 1-866-475-8222. Visit GSKDirect.com or contact your GSK Sales Representative.

     

    Schedule a GSK Vaccine Business Review today to find out more about our Premium Partner program. For more information about PEDIARIX, please see the Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

     

    Please see Important Safety Information in this video and full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Keep your DTaP immunization routine running smoothly. Order PEDIARIX today by calling 1-866-475-8222, by visiting GSKDirect.com, or by contacting your GSK Sales Representative.

     

    Thank you for watching this video. For more information about PEDIARIX, please see the Important Safety Information and full Prescribing Information at PEDIARIX.com.

     

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    Important Safety Information for PEDIARIX

    • Contraindications for PEDIARIX are: severe allergic reaction (for example, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

    • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines

    • The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (such as, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Important Safety Information for PEDIARIX.

     

    Contraindications for PEDIARIX are: severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders.

     

    In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines.

     

    The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105oF, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine.

     

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    Important Safety Information for PEDIARIX (cont’d)

    • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
    • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
    • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton.

     

    Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

     

    For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

     

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    Important Safety Information for PEDIARIX (cont’d)

    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

    • In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite

    • Vaccination with PEDIARIX may not result in protection in all vaccine recipients

     

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2024 GSK or licensor.

    PMUS-PDRVID240005 November 2024

    Produced in USA.

     

    Please see full Prescribing Information available at PEDIARIX.com.

    [PEDIARIX logo (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)] [GSK logo]

     

    DR. LEN FRIEDLAND

    Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination.

     

    In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite.

     

    Vaccination with PEDIARIX may not result in protection in all vaccine recipients.