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Vaccinating Against Pertussis in Your Community.
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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.
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Why Is It Important to Vaccinate Appropriate Patients Against Pertussis?
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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?
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What would you imagine has been the impact of pertussis on patients, their families, and medical practices?
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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.
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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. 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.
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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.
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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.
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.
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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.
Updated April 12, 2024. Accessed December 5, 2024. 2. Centers for Disease Control and Prevention. 2024 Provisional pertussis surveillance report. Updated January 2025. Accessed January 20, 2025.
DR. LEN FRIEDLAND
Pertussis is a serious, highly contagious disease which is active in the United States.
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[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. 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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…
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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.
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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 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.
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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.
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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.
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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.
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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 …
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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).
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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:
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.
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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: 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.
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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…
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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.
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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)
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.
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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.
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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.
