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U.S. FDA Licenses DAPTACEL(R) Vaccine for the Fifth Consecutive Dose in the Pediatric DTaP Immunization Series
Date:3/13/2008

- DAPTACEL vaccine is licensed for the entire immunization series to

protect against diphtheria, tetanus, and pertussis -

SWIFTWATER, Pa. and LYON, France, March 13 /PRNewswire-FirstCall/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed DAPTACEL(R) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) to be administered as a fifth consecutive diphtheria, tetanus, and acellular pertussis (DTaP) vaccine dose for children 4 years through 6 years of age for the prevention of diphtheria, tetanus, and pertussis.

In 2002, DAPTACEL vaccine was licensed by the FDA for four consecutive doses, currently administered at 2, 4, 6, and 15 to 20 months of age. The approval of the fifth consecutive dose of DAPTACEL vaccine completes the FDA license for the entire five-dose DAPTACEL vaccine series enabling health-care professionals to administer the same brand of DTaP vaccine for the series as recommended by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).

The fifth consecutive dose of DAPTACEL vaccine also provides a convenient fit with the CDC's recommended immunization schedule. According to the ACIP, AAP, and AAFP recommendations, these five doses should be administered before 7 years of age.

The safety of DAPTACEL vaccine was demonstrated in a clinical trial involving 487 children across 22 different trial sites who received DAPTACEL vaccine as a fifth consecutive dose. Out of the subjects included in the safety examination in this study, 98 percent (477/487) completed the 180-day safety follow-up after receiving the fifth dose. Of the 10 children (2 percent of 487) who did not complete the 180-day follow-up, 3 were lost to follow-up, 6 were discontinued due to no
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SOURCE sanofi-aventis
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