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Wyeth-Lederle Acel-Imune results in less drowsiness than whole-cell DTP.

Executive Summary

WYETH-LEDERLE ACEL-IMUNE ASSOCIATED WITH LESS DROWSINESS THAN WHOLE-CELL DTP vaccine in pediatric safety trials, the company said. In German efficacy trials of Acel-Imune (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed), 21% of children receiving first-dose Acel-Imune experienced drowsiness, compared with 38% of whole-cell DTP vaccine recipients, according to data presented by the company at an October meeting of FDA's Vaccines & Related Biological Products Advisory Committee.

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