EFFICACY

Demonstrated efficacy against typical* and milder† pertussis in infants

A 3-dose series of INFANRIX, the DTaP component of PEDIARIX, demonstrated efficacy against pertussis in infants.1,2,‡

Protective efficacy of INFANRIX against pertussis following 3 doses1,2,‡

Protective efficacy of INFANRIX against pertussis following 3 doses1,2,‡

Protective efficacy of INFANRIX against pertussis following 3-doses graph

CI=confidence interval; DTaP=diphtheria, tetanus, and acellular pertussis; WHO=World Health Organization.

*WHO-defined typical pertussis is ≥21 days of paroxysmal cough with infection confirmed by culture and/or serologic testing.2

†Clinically milder disease is infection confirmed by culture and/or serologic testing with >7 or ≥14 days of any cough.2

‡The mean length of follow-up was 17 months, beginning 30 days after the third dose of vaccine.2

Study Design

A double-blind, randomized, active diphtheria and tetanus toxoids (DT)-controlled trial assessed the absolute protective efficacy of INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) against pertussis when administered at 2, 4, and 6 months of age (N=5951).1,2

The efficacy of the pertussis component of PEDIARIX, which does not have a well-established correlate of protection, was determined in clinical trials of INFANRIX.1

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 were drowsiness, irritability/fussiness, and loss of appetite, reported in approximately 15% to 60% of subjects, depending on event and dose number.2

 

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

Efficacy against typical pertussis*: 86% (95% CI: 79, 91)

In an extended, unblinded follow-up period among children 3 to 6 years of age, the efficacy of INFANRIX against WHO-defined pertussis was 86% (95% CI: 79, 91). Thus, protection against pertussis in children administered 3 doses of INFANRIX in infancy was sustained to 6 years of age.1,2

PEDIARIX is approved for use as a 3-dose primary series and by itself does not constitute a complete vaccination course for DTaP.1

*WHO-defined typical pertussis is ≥21 days of paroxysmal cough with infection confirmed by culture and/or serologic testing.2

Watch a video about the efficacy and safety of PEDIARIX.

  • Video transcript

    TEXT ONSCREEN:

    Vaccinating Against Pertussis in Your Community.

     

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

     

    TEXT ONSCREEN:

    Why Is It Important to Vaccinate Appropriate Patients Against Pertussis?

     

    DR. LEN FRIEDLAND:

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

     

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

     

    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.

     

    TEXT ONSCREEN:

    CDC = Centers for Disease Control and Prevention.

     

    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 with whopping cough]

     

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

     

    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.

     

    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.

     

    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.

     

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

     

    Here you can see the cases of pertussis that were reported in the U.S. in 2019, as well as the incidence per 100,000 people. 

     

    TEXT ONSCREEN:

    15,662 pertussis cases in the United States, Provisional, 2019. 4.3 incidence per 100,000 people.

     

    DR. LEN FRIEDLAND:

    These cases are from the CDC's 2019 provisional pertussis surveillance report. Please note surveillance data have limitations, and are often incomplete. About one half of pertussis cases in 2019 among children 6 months to 6 years of age, had unknown pertussis vaccination history. Surveillance data by itself cannot be used to interpret vaccine effectiveness or assess risk, as it's often 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.

     

    TEXT ONSCREEN:

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

     

    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. . .

     

    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 7th 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 7th 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 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

     

    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.

     

    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.

     

    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.

     

    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.

     

    [Chart on screen: PEDIARIX Includes Antigens for DTaP, hepatitis B, and Poliomyelitis]

     

    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.

     

    [Chart on screen: The DTaP content of PEDIARIX is identical to that of INFARIX]

    Let’s examine the data that support the demonstrated efficacy of PEDIARIX against pertussis, and the safety profile of PEDIARIX, which has been studied in 14 safety 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.

     

    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.

     

    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.

     

    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.

     

    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.

     

     

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

     

    TEXT ONSCREEN:

    Study Design: A prospective, controlled, household contact trial of INFANRIX assessed protective efficacy against WHO-defined pertussis.*

    *21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing. WHO=World Health organization.

     

    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.

     

    TEXT ONSCREEN:

    Study Design: 3 doses of INFANRIX administered at 3, 4, and 5 months of age to >22,000 infants.

     

    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.

     

    TEXT ONSCREEN:

    Study Design: Household contacts of index cases monitored for pertussis.

     

    DR. LEN FRIEDLAND:

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

     

    TEXT ONSCREEN:

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

     

    DR. LEN FRIEDLAND:

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

     

    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.

     

    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 

     

    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.

     

    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 caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions.

     

    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 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.

     

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

     

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

     

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

     

    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.

     

    This established safety profile has been reinforced by a postmarketing safety surveillance study showing no statistically significant differences between PEDIARIX and historical DTaP controls with regard to seizures or medically-attended fever.

     

    In comparative studies, administration of PEDIARIX 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).

     

    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.

     

    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.

     

    TEXT ONSCREEN:

    Study Design: CDC prefers that doses of DTaP vaccine in a series come from the same manufacturer. Example: HepB, DTaP, and IPV from Birth Through 6 Years of Age [chart]

     

    DR. LEN FRIEDLAND:

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

     

    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.

     

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

     

    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.

     

    TEXT ONSCREEN:

    Established safety profile and proven efficacy against pertussis.

    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.

     

    You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report or call 1-800-822-7967.

     

    TEXT ONSCREEN:

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