TITLE

Endpoints in vaccine trials

AUTHOR(S)
Hudgens, Michael G.; Gilbert, Peter B.; Self, Steven G.
PUB. DATE
April 2004
SOURCE
Statistical Methods in Medical Research;Apr2004, Vol. 13 Issue 2, p89
SOURCE TYPE
Academic Journal
DOC. TYPE
journal article
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.
ACCESSION #
12916770

 

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