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Aventis DTaP vaccine

Executive Summary

FDA's Vaccines & Related Biological Products Advisory Committee recommends Nov. 3 that additional safety data on the diphtheria, tetanus and acellular pertussis vaccine be collected prior to approval because of the small sample size receiving a fourth dose of the product. FDA noted that the pertactin antibody response differed among U.S. infants and infants in Sweden where trials were conducted. The committee voted that the data is adequate to support efficacy of the acellular pertussis component of the product. The PLA for the vaccine, marketed as Tripacel outside the U.S., was submitted in May 1996
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PS036836

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