In a U.S. study (Study 055) that enrolled children aged 4 to 6 years, KINRIX was administered concomitantly at separate sites with MMR vaccine (Merck & Co., Inc.) (n = 237) or with MMR vaccine and varicella vaccine (Merck & Co., Inc.) (n = 239). Immune responses to the antigens contained in KINRIX were measured approximately 1 month (28 to 48 days) after vaccination. Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) after the receipt of KINRIX administered concomitantly with MMR vaccine and varicella vaccine were non-inferior to immune responses following concomitant administration of KINRIX administered with MMR vaccine.
- 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.
- Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.
KINRIX is available in 0.5-mL single-dose, disposable, prefilled TIP‑LOK syringes (packaged without needles):
NDC 58160-812-43 Syringe in Package of 10: NDC 58160-812-52
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.
Provide the following information to the parent or guardian:
- Inform of the potential benefits and risks of immunization with KINRIX.
- Inform about the potential for adverse reactions that have been temporally associated with administration of KINRIX or other vaccines containing similar components.
- 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).
INFANRIX, KINRIX, PEDIARIX, and TIP‑LOK are trademarks owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its respective owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.
Manufactured by GlaxoSmithKline Biologicals
Rixensart, Belgium, U.S. License 1617, and
GSK Vaccines GmbH
Marburg, Germany, U.S. License 1617
Distributed by GlaxoSmithKline
Durham, NC 27701
©2023 GSK group of companies or its licensor.
PRINCIPAL DISPLAY PANEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
For Use from 4 through 6 Years of Age
10 Disposable Single-Dose Prefilled TIP-LOK Syringes each containing one 0.5-mL dose
TIP-LOK syringes are compatible with LUER-LOK needles
NEEDLES NOT INCLUDED
©2018 GSK group of companies or its licensor.
KINRIX and TIP-LOK are trademarks owned by or licensed to the GSK group of companies.
LUER-LOK is a trademark owned by or licensed to Becton, Dickinson, and Company.
Made in Belgium
| KINRIX |
diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspension
|Labeler — GlaxoSmithKline Biologicals SA (372748392)|
Revised: 01/2023 GlaxoSmithKline Biologicals SA
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