In a U.S. study, INFANRIX was given concomitantly, at separate sites, with Hib conjugate vaccine (Sanofi Pasteur SA) at 2, 4, and 6 months of age. Subjects also received ENGERIX-B and oral poliovirus vaccine (OPV). One month after the third dose of Hib conjugate vaccine, 90% of 72 infants had anti-PRP (polyribosyl-ribitol-phosphate) ≥1.0 mcg/mL.
In a U.S. study, INFANRIX was given concomitantly, at separate sites, with ENGERIX-B, IPV (Sanofi Pasteur SA), pneumococcal 7-valent conjugate (PCV7), and Hib conjugate vaccines (Wyeth Pharmaceuticals Inc.) at 2, 4, and 6 months of age. Immune responses were measured in sera obtained approximately 1 month after the third dose of vaccines. Among 121 subjects who had not received a birth dose of hepatitis B vaccine, 99.2% had anti-HBsAg (hepatitis B surface antigen) ≥10 mIU/mL following the third dose of ENGERIX-B. Among 153 subjects, 100% had anti-poliovirus 1, 2, and 3, ≥1:8 following the third dose of IPV. Although serological correlates for protection have not been established for the pneumococcal serotypes, a threshold level of ≥0.3 mcg/mL was evaluated. Following the third dose of PCV7 vaccine, 91.8% to 99.4% of subjects (n = 146-156) had anti-pneumococcal polysaccharide ≥0.3 mcg/mL for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 73.0% had a level ≥0.3 mcg/mL for serotype 6B.
- Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.
- Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.
- Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register. December 13, 1985;50(240):51002-51117.
- Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-15):1-48.
Provide the following information to the parent or guardian:
- Inform of the potential benefits and risks of immunization with INFANRIX, and of the importance of completing the immunization series.
- Inform about the potential for adverse reactions that have been temporally associated with administration of INFANRIX or other vaccines containing similar components.
- Instruct to report any adverse events to their healthcare provider.
- Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
ENGERIX-B, INFANRIX, PEDIARIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies.
Manufactured by GlaxoSmithKline Biologicals
Rixensart, Belgium, U.S. License 1617
GSK Vaccines GmbH
Marburg, Germany, U.S. License 1617
Distributed by GlaxoSmithKline
Research Triangle Park, NC 27709
©2019 GSK group of companies or its licensor.
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.
|INFANRIX diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed suspension|
|Labeler — A-S Medication Solutions (830016429)|
|A-S Medication Solutions||830016429||RELABEL (50090-2883)|
Revised: 01/2020 A-S Medication Solutions
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