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Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose

On June 24, 2008, the Food and Drug Administration licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine, DTaP-IPV (Kinrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Kinrix is licensed for use as the fifth dose of the DTaP vaccine series and the fourth dose of the IPV series in children aged 4 -- 6 years whose previous DTaP vaccine doses were DTaP (Infanrix, GlaxoSmithKline) and/or DTaP-Hepatitis B-IPV (Pediarix, GlaxoSmithKline) for the first 3 doses and DTaP (Infanrix) for the fourth dose (1,2). DTaP-IPV administered to children aged 4 -- 6 years would reduce by one the number of injections needed to complete DTaP and IPV immunization. This report summarizes the indications for Kinrix and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.

ACIP reviewed data on the safety and immunogenicity of DTaP-IPV (Kinrix). On the basis of these data, expert opinion of the ACIP Combination Vaccines Workgroup, and feedback from ACIP liaison organizations including the American Academy of Pediatrics and the American Academy of Family Physicians, ACIP endorsed the licensed indications and offered the following guidance for use of DTaP-IPV. On June 26, ACIP voted to include DTaP-IPV in the federal Vaccines for Children Program.

The individual antigens (diphtheria, tetanus, and pertussis toxoids, filamentous hemagglutinin, pertactin, and poliovirus types 1, 2, and 3) contained in combined DTaP-IPV are identical to the antigens contained in GlaxoSmithKline's DTaP (Infanrix) and DTaP-Hepatitis B-IPV (Pediarix) and have been described previously (3). DTaP-IPV contains no preservatives. DTaP-IPV is administered as an intramuscular injection, preferably into the deltoid region. Two clinical trials conducted in U.S. children aged 4 -- 6 years showed that combined DTaP-IPV and separately administered DTaP and IPV vaccines had comparable safety and reactogenicity profiles, with or without a co-administered second dose of measles, mumps, and rubella (MMR) vaccine (3,4). The immunogenicity of all antigens was similar between the treatment groups, with or without a co-administered second dose of MMR vaccine.

Indications and Guidance for Use

DTaP-IPV (Kinrix) is indicated for use as the fifth dose of DTaP and fourth dose of IPV in children aged 4 -- 6 years who received DTaP (Infanrix) and/or DTaP-Hepatitis B-IPV (Pediarix) as the first 3 doses and DTaP (Infanrix) as the fourth dose (1,2). This vaccine should not be administered to children aged <4 years or >7 years; however, if DTaP-IPV (Kinrix) is inadvertently administered for an earlier dose of the DTaP and/or IPV series, the dose should be counted as valid and does not need to be repeated provided minimum interval requirements have been met (5). Data are limited on the safety and immunogenicity of interchanging DTaP vaccines from different manufacturers (6). ACIP recommends that, whenever feasible, the same manufacturer's DTaP vaccines should be used for each dose in the series; however, vaccination should not be deferred because the type of DTaP previously administered is unavailable or unknown (6).

References

  1. CDC. Recommended immunization schedules for persons aged 0 -- 18 years -- United States, 2008. MMWR 2008;57(1).
  2. Food and Drug Administration. Product approval information: package insert. Kinrix (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine). Available at http://www.fda.gov/cber/products/kinrix.htm.
  3. Black S, Friedland LR, Schuind A, Howe B for the GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4 -- 6 years. Vaccine 2006;24:6163 -- 71.
  4. Black S, Friedland LR, Ensor K, Weston WM, Howe B, Klein NP. Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4 -- 6 years of age. Pediatr Infect Dis J 2008;27:341 -- 6.
  5. CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-15).
  6. Greenberg DP, Pickering LK, Senders SD, et al. Interchangeability of 2 diphtheria-tetanus-acellular pertussis vaccines in infancy. Pediatrics 2002;109:666 -- 72.

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Date last reviewed: 10/1/2008

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