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J Infect Dis. 2014 Apr 1;209 Suppl 1:S28-31. doi: 10.1093/infdis/jit532.

Clinical evaluation of pertussis vaccines: US Food and Drug Administration regulatory considerations.

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  • 1US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland.


The resurgence of pertussis in the United States has stimulated considerable public health interest in developing new vaccination strategies to improve control of pertussis. The purpose of this article is to review the US Food and Drug Administration's regulatory framework for the prelicensure clinical evaluation of preventive vaccines and the clinical approaches that have been used to demonstrate effectiveness of US-licensed vaccines containing an acellular pertussis component.


pertussis vaccines; regulatory pathways; vaccine effectiveness

[PubMed - indexed for MEDLINE]
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