Endpoints in vaccine trials-Reference-Cited by-同舟云学术

Endpoints in vaccine trials

Published:2004-04 Issue:2 Volume:13 Page:89-114
ISSN:0962-2802
Container-title:Statistical Methods in Medical Research
language:en
Short-container-title:Stat Methods Med Res

Author:

Hudgens Michael G¹,Gilbert Peter B²,Self Steven G²

Affiliation:

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

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

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.

Publisher

SAGE Publications

Subject

Health Information Management,Statistics and Probability,Epidemiology

Link

http://journals.sagepub.com/doi/pdf/10.1191/0962280204sm356ra

Reference135 articles.

1. Fundamentals of Clinical Trials

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