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- Title
Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations.
- Authors
Farizo, Karen M.; Burns, Drusilla L.; Finn, Theresa M.; Gruber, Marion F.; Pratt, R. Douglas
- Abstract
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.
- Subjects
WHOOPING cough vaccines; UNITED States. Food &; Drug Administration; VACCINE effectiveness; PREVENTIVE medicine; PUBLIC health
- Publication
Journal of Infectious Diseases, 2014, Vol 209, Issue suppl_1, pS28
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jit532