On Jun. 20, 2008, the Food and Drug Administration (FDA) licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP), inactivated poliovirus vaccine (IPV), and Haemophilus influenzae type b conjugate (tetanus toxoid [TT] conjugate) vaccine, DTaP-IPV/Hib (Pentacel, Sanofi Pasteur, Swiftwater, Pennsylvania), for use as a four-dose series in infants and children at ages 2, 4, 6, and 15 — 18 months. This report summarizes the indications for Pentacel 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/Hib (Pentacel). 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 indicationsand offered the following guidancefor use of DTaP-IPV/Hib. On June 26, ACIP voted to include DTaP-IPV/Hib in the federal Vaccines for Children Program.

Each dose of DTaP-IPV/Hib contains the same diphtheria and tetanus toxoids and pertussis antigens (inactivated pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin, and fimbriae types 2 and 3) as the FDA-licensed DTaP vaccine Daptacel(Sanofi Pasteur, Toronto, Canada) but contains an increased amount of inactivated PT and FHA. The poliovirus component of DTaP-IPV/Hib contains the same strains and amount of inactivated poliovirus types 1, 2, and 3 as the polio vaccine Poliovax (Sanofi Pasteur, Toronto, Canada). The Hib component is identical to ActHib (Haemophilus influenzae type b capsular polysaccharide [polyribosyl-ribitol-phosphate {PRP}] covalently bound to tetanus toxoid) (Sanofi Pasteur, Swiftwater, Pennsylvania). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute a lyophilized ActHIB vaccine component. Components should not be administered separately. DTaP-IPV/Hib does not contain thimerosal.