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Statistical Methods in Medical Research
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Endpoints in vaccine trials

Michael G Hudgens

Statistical Center For HIV/AIDS Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA, mhudgens{at}bios.unc.edu

Peter B Gilbert

Statistical Center For HIV/AIDS Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

Steven G Self

Statistical Center For HIV/AIDS Research and Prevention, Program in Biostatistics, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA

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.

Statistical Methods in Medical Research, Vol. 13, No. 2, 89-114 (2004)
DOI: 10.1191/0962280204sm356ra
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 Am J Trop Med HygHome page
N. MAIRE, J. J. APONTE, A. ROSS, R. THOMPSON, P. ALONSO, J. UTZINGER, M. TANNER, and T. SMITH
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Am J Trop Med Hyg, August 1, 2006; 75(2_suppl): 104 - 110.
[Abstract] [Full Text] [PDF]


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