title: Clinical evaluation of pertussis vaccines: US Food and Drug Administration regulatory considerations.
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.
authors.affiliation: US Food and Drug Administration, Center for Biologics Evaluation and Research, Rockville, Maryland.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Farizo
authors.forename: Drusilla L
authors.initials: DL
authors.lastname: Burns
authors.forename: Theresa M
authors.initials: TM
authors.lastname: Finn
authors.forename: Marion F
authors.initials: MF
authors.lastname: Gruber
authors.forename: R Douglas
authors.initials: RD
authors.lastname: Pratt
mesh_terms: D021821:Communicable Diseases, Emerging / Q000453:epidemiology / Q000517:prevention & control; D017277:Drug Approval; D006801:Humans; D010567:Pertussis Vaccine / Q000009:adverse effects* / Q000276:immunology*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D014917:Whooping Cough / Q000453:epidemiology / Q000517:prevention & control
chemical_list: D010567:Pertussis Vaccine
keywords: pertussis vaccines; regulatory pathways; vaccine effectiveness