The following Q&A was designed as a quick reference guide to INFANRIX. 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.
Q: How effective is INFANRIX? A:Two separate studies demonstrated the protective efficacy of 3 doses of INFANRIX against World Health Organization (WHO)–defined typical pertussis (≥21 days of
paroxysmal cough and laboratory confirmation) after three doses of
vaccine. In one clinical trial sponsored by the National Institutes of
Health (NIH), those administered 0.5 mL INFANRIX (N=4,481) on the
usual 2-, 4-, and 6-month schedule resulted in [1]:
a protective efficacy of 84% after 3 doses at month 7
A prospective blinded efficacy trial was conducted employing a household contact study design. For this study 0.5 mL of INFANRIX was administered on 3-, 4-, and 5- month schedule to 22,505 vaccinated infants taking part in a large safety and immunogenicity trial. Pediatricians were asked to monitor households with a first potential case (index case) of typical pertussis which was identified by spontaneous presentation to the physician. Of the 173 unvaccinated household contacts, 96 developed WHO-defined pertussis (≥21 days of paroxysmal cough and laboratory confirmation), as compared to 7 of 112 contacts vaccinated with INFANRIX. The protective efficacy of INFANRIX was calculated to be 89% with no indication of waning of protection up until the time of the booster. When the definition of pertussis was expanded to include clinically milder disease, with infection confirmed by culture and/or serologic testing, the efficacy of INFANRIX against ≥7days of paroxysmal cough was 81% (n=112).
Q: Are there any adverse reactions associated with INFANRIX? A:Approximately 92,000 doses of INFANRIX have been administered in clinical studies. Local adverse events may occur at the site of injection and include erythema, swelling and tenderness. Systemic adverse events may include fever, irritability, and drowsiness. Studies have shown the rate of local injection site reactions (erythema and swelling) and fever increased with successive doses of INFANRIX.
For complete information on this vaccine, please see the prescribing information.
Q: Can INFANRIX be used to complete an immunization course started with another DTaP vaccine? A:Interchanging INFANRIX and DTaP vaccines from different manufacturers for successive doses of the vaccination series is not recommended because data are limited regarding the safety and efficacy of such regimens.
INFANRIX may be used to complete a DTaP immunization series initiated with PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] manufactured by GlaxoSmithKline Biologicals, because diphtheria, tetanus, and pertussis components of INFANRIX are the same as those in PEDIARIX. However, the safety and efficacy of INFANRIX in such infants and children have not been evaluated.
Q: What is the dosing regimen for pediatric patients using INFANRIX? A:Healthy children, between the ages of 6 weeks and 7 years (prior to seventh birthday), should be administered 0.5 mL dose of INFANRIX as a 5 dose series:
The primary immunization course of 3 doses should be administered at 2-, 4-, and 6-months of age. The recommended interval between the first three doses is 8 weeks, with a minimum interval of 4 weeks.
The booster immunization course of 2 doses should be administered at 15-20 months and at 4-6 years of age. The recommended interval between the first third and fourth dose is 6-12 months.
The fifth dose is recommended before entry to kindergarten or elementary school, and is not needed if the fourth dose was given after the fourth birthday.
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with INFANRIX. There is no need to start the series over again, regardless of the amount of time elapsed between doses.
Preterm infants should be vaccinated according to their chronological age from birth.[1]
Q: Are there special requirements for administering INFANRIX? A:INFANRIX should be administered by intramuscular injection. It should not be administered in the gluteal region; such injections may result in suboptimal response. The vaccine must be shaken vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking. INFANRIX should not be mixed with any other vaccine in the same syringe or vial. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.
Q: Does INFANRIX require special storage or handling? A:INFANRIX should be refrigerated at 2° to 8° C (36° to 46° F). Do not freeze; frozen products should be discarded. Do not use after expiration date shown on the label.
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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