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North American Vaccine/Abbott Certiva

Executive Summary

Labeling for DTaP vaccine states that it is recommended for four-dose schedule in diphtheria-tetanus-pertussis series, or to complete the series in children who have received one or two doses of whole-cell DTP vaccines. It is also recommended as the fifth dose in children who have received four whole-cell doses or three whole-cell doses followed by a dose of Certiva. "At this time, there are no data to establish the frequency of adverse events following a fifth dose of Certiva in children who previously received four doses of Certiva," labeling states. North American Vaccine is conducting a five-consecutive dose safety trial ("The Pink Sheet" Aug. 3, p. 3)
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PS032644

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