Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations | Zendy

Karen M. Farizo | Zendy; Drusilla Burns | Zendy; Theresa M. Finn | Zendy; Marion F. Gruber | Zendy; Raymond D. Pratt | Zendy

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Clinical Evaluation of Pertussis Vaccines: US Food and Drug Administration Regulatory Considerations

Author(s) -

Karen M. Farizo,

Drusilla Burns,

Theresa M. Finn,

Marion F. Gruber,

Raymond D. Pratt

Publication year - 2014

Publication title -

the journal of infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.69

H-Index - 252

eISSN - 1537-6613

pISSN - 0022-1899

DOI - 10.1093/infdis/jit532

Subject(s) - food and drug administration , pertussis vaccine , medicine , public health , vaccination , whooping cough , drug , environmental health , administration (probate law) , immunization , immunology , pharmacology , political science , pathology , immune system , law

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.

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