title: Endpoints in vaccine trials.
abstract: In this paper we discuss statistical considerations regarding endpoints in preventive vaccine trials. Brief discussion is given to preclinical, Phase I, and Phase II trials, with the bulk of attention paid to endpoint choice and analysis in Phase III efficacy trials. In addition to traditional efficacy measures of vaccine effects for immunized individuals, consideration is given to waning, strain specific efficacy, correlates of protective immunity, postinfection endpoints, and cluster randomized trials.
authors.affiliation: Statistical Center For HIV/AIDS Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. mhudgens@bios.unc.edu
authors.forename: Michael G
authors.initials: MG
authors.lastname: Hudgens
authors.forename: Peter B
authors.initials: PB
authors.lastname: Gilbert
authors.forename: Steven G
authors.initials: SG
authors.lastname: Self
mesh_terms: D002986:Clinical Trials as Topic; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D014481:United States; D014612:Vaccines / Q000627:therapeutic use*
chemical_list: D014612:Vaccines