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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.
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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.
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[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.
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[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.
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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).
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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.
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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.
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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).
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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.
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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.
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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.
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[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. 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. 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
