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| PEDIARIX Frequently Asked Questions |
The following Q&A was designed as a quick reference guide to PEDIARIX. Each question and answer covers a different aspect of the vaccine in a clear, concise manner, and should help you find the information you need quickly and easily.
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Q: Does PEDIARIX have a proven safety profile?
A: A proven safety profile has been established in clinical trials involving the administration of 20,739 doses to 7,028 infants as a primary vaccination series. [7]
For complete information on this vaccine, please see the prescribing information.
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Q: How frequently do adverse events, such as local reactions and fever, occur?
A: A clinical study involving over 3,500 infants was conducted to evaluate the safety and reactogenicity of PEDIARIX given concomitantly with Hib vaccine. [7] Although this study found a significant increase in fever for infants given PEDIARIX + Hib compared to separate injections, there were no significant differences between groups in the rates of high fever (>103.1°F).
For complete information on this vaccine, please see the prescribing information
Contact Us to report any possible adverse events.
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In a U.S. lot consistency study, reactogenicity was assessed in 482 infants after 3 doses of PEDIARIX were administered separately, but concomitantly with Hib vaccine. In this study, most local and general adverse events were reported as mild (Grade "1") or moderate (Grade "2") in intensity. Severe adverse events (Grade "3"), defined as events that would prevent normal daily activity, occurred infrequently, at rates of 1.5% or less. In a U.S. study in which PEDIARIX was co-administered with Prevnar® [Pneumococcal 7-valent Conjugate Vaccine, (Diphtheria CRM197
Protein)]§ and Hib vaccine, a higher rate of fever ≥100.4° was observed following the first dose in the PEDIARIX group compared to the group receiving separate vaccines. There were no significant differences between groups in the rates of high fever (>103.1°F). Across all studies, rates of most other solicited adverse events following PEDIARIX were similar to rates observed following separately administered U.S.- licensed vaccines.[7]
§ Prevnar is a registered trademark of Wyeth Pharmaceuticals.
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Q: Can combination vaccines, such as PEDIARIX, overload my patients' immune systems?
A: No. Immunologists have estimated that the immune system is capable of responding to millions of antigens. And with vaccines, the immune system responds to significantly fewer antigens than with natural infection. Some vaccines, such as hepatitis B and Hib, contain only 1 antigen. [3,4]
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Q: Can PEDIARIX be given to children who have received a birth dose of hepatitis B vaccine?
A: Yes. Infants born of HBsAg-negative mothers and who have received a dose of hepatitis B vaccine, at or shortly after birth, may be administered 3 doses of PEDIARIX according to the recommended schedule. However, data are limited regarding the safety and immunogenicity of PEDIARIX in such infants.[1] The ACIP, AAP, and AAFP recommendations state that four doses of hepatitis B vaccine, including the birth dose, may be administered if a combination vaccine is used to complete the series.[5]
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PEDIARIX: Immunogenicity Profile
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Q: Does the 2-, 4-, and 6-month dosing schedule with PEDIARIX provide adequate protection against hepatitis B?
A: Yes. Clinical studies have demonstrated that the administration of hepatitis B vaccine in combination at 2, 4, and 6 months induces a seroprotective immune response similar to that achieved with administration of hepatitis B vaccine on a birth, 1-month, and 6-month schedule.[6] Additionally, the PEDIARIX immunization schedule (2, 4, and 6 months) adheres to current ACIP, AAP, and AAFP recommendations.[5]
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Q: Does PEDIARIX provide the same protection against poliovirus as the licensed inactivated polio vaccine?
A: Yes. A clinical study has demonstrated that immunogenicity against poliovirus with PEDIARIX at 2, 4, and 6 months of age is similar to the licensed inactivated polio vaccine (IPOL® Inactivated Poliovirus Vaccine, IPV])¶ [6]. Additionally, the PEDIARIX immunization schedule (2, 4, and 6 months) adheres to the current ACIP, AAP, and AAFP recommendations.[5]
¶ IPOL is a registered trademark of Sanofi Pasteur.
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FAQ: Interchangeability / Concomitant
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Q: How do I complete the primary series with PEDIARIX following DTaP from another manufacturer?
A: It is recommended that PEDIARIX be given for all 3 doses because data are limited regarding the safety and efficacy of using acellular pertussis vaccines from different manufacturers for successive doses of the pertussis vaccination series. PEDIARIX is not recommended for completion of the 3-dose infant DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer because no data are available regarding the efficacy of using such a regimen. [1] The ACIP/AAP/AAFP recommend that immunization providers who cannot determine which DTaP vaccine was previously administered, or who do not have the same vaccine, should use any of the licensed acellular pertussis products to continue the immunization series. [7]
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Q: PEDIARIX provides 3 DTaP injections for the primary series. How do I complete the 4th and 5th DTaP doses?
A: Use Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), a widely used DTaP vaccine proven to be immunogenic and safe.[1,8] The pertussis antigen components of INFANRIX are the same as those components in PEDIARIX; therefore, these children should receive INFANRIX as their fourth and fifth dose of DTaP. However, data are insufficient to evaluate the safety of INFANRIX following 3 doses of PEDIARIX. [1,8]
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Q: Can I use PEDIARIX for a child who is partially immunized with another IPV vaccine? If I start the polio series with PEDIARIX, can I use a different IPV brand for the 4th dose?
A: Yes, in both instances. PEDIARIX may be used to complete a 3-dose IPV vaccination series initiated with IPV from a different manufacturer. PEDIARIX is not indicated for use as a booster dose; therefore, IPOL should be used for the fourth IPV dose. PEDIARIX contains the same viral types, strains, and antigen contents as IPOL. [1,9]
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Q: Can I use PEDIARIX in a child partially immunized with another hepatitis B vaccine?
A: Yes. PEDIARIX may be used to complete a hepatitis B vaccination series initiated with a licensed hepatitis B vaccine (recombinant) from a different manufacturer. [1]
Modified Schedules: Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine: Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of PEDIARIX according to the recommended schedule. However, data are limited regarding the safety of PEDIARIX in such infants (see ADVERSE REACTIONS). There are no data to support the use of a 3-dose series of PEDIARIX in infants who have previously received more than one dose of hepatitis B vaccine. PEDIARIX may be used to complete a hepatitis B vaccination series in infants who have received 1 or more doses of Hepatitis B Vaccine (Recombinant) and who are also scheduled to receive the other vaccine components of PEDIARIX. However, the safety and efficacy of PEDIARIX in such infants have not been studied. [1]
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Q: Can PEDIARIX be given concomitantly with Hib vaccine?
A: Yes. In clinical trials, PEDIARIX was routinely administered concomitantly, at separate sites, with Hib vaccine. No effect on the safety or immunogenicity profile of either vaccine was observed. [1,2,6] When concomitant administration of Hib vaccine is required, it should be given with a separate syringe and at a different injection site.[1]
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FAQ: Integrating PEDIARIX
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Q: How can I integrate PEDIARIX into the immunization schedule of patients who have been partially immunized with other vaccines?
A: At any point in time infants will be at various stages of immunization depending on their age and immunization history. When deciding to complete a vaccination series with PEDIARIX the ACIP states that "vaccines from different manufacturers that protect against the same disease may be administered interchangeably in sequential doses in the immunization series for an individual patient (e.g., hepatitis A [HepA], HepB, and Hib)."[7] PEDIARIX may be used to complete the primary series in infants who have received one or two doses of Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).[1] PEDIARIX is not indicated for completion of the primary series in infants who have received doses of DTaP from other manufacturers because no data are available. In addition, PEDIARIX may be used to complete a vaccination series initiated with IPV from a different manufacturer.
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Q: Will the conversion to PEDIARIX inconvenience or confuse my staff and increase the potential for medical errors?
A: Integrating PEDIARIX into your practice's immunization schedule will reduce the number of injections given within the first 6 months of life and may initially require some changes. However, the long-term convenience of incorporating PEDIARIX will be substantial. Additionally, PEDIARIX in Tip-Lok® prefilled syringes comes with a peel-off label with lot and expiry information that can be easily transferred into medical records. This may help reduce the potential for transcription errors as well as save time and offer convenience to medical staff. Also, as your office transitions from integration to full use of PEDIARIX, your office will be saving storage space within the refrigerator as you will only have to store one vaccine versus three for the majority of your DTaP, HepB, and IPV needs.
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Important Safety Information
In clinical studies, adverse events included injection-site reactions (pain, redness, or swelling), fever and fussiness for PEDIARIX and INFANRIX, and drowsiness for INFANRIX. As with other vaccines, rare adverse events may occur. Administration with PEDIARIX was associated with higher rates of fever relative to separately administered vaccines (see Adverse Reactions section of the package insert). PEDIARIX and INFANRIX are contraindicated in people with known hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B in PEDIARIX. As with any vaccine, vaccination may not protect 100% of susceptible individuals
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