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Vaccine trials

Farrington, C. P. and Miller, E. (2001). Vaccine trials. Molecular Biotechnology, 17(1) pp. 43–58.

DOI (Digital Object Identifier) Link: http://dx.doi.org/10.1385/MB:17:1:43
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Abstract

This article reviews some of the issues involved in evaluating vaccines in humans. Vaccine trials are required for licensure and are essential for demonsrating a vaccine’s safety and protective efficacy. The formal framework of phase I, II, and III trials is described, with particular emphasis on the choice of hypotheses, trial design, and biases that arise in the context of vaccine trials. However, some aspects of a vaccine’s performance cannot be evaluated in clinical trials owing to their relatively small size. Thus, vaccine evaluation must continue after licensure, for example, to evaluate the vaccine with respect to rare reactions, duration of protection, and ecological effects. The article reviews some of the methods commonly used for post-licensure studies of vaccine efficacy and safety.

Item Type: Journal Article
Copyright Holders: 2001 Humana Press Inc.
ISSN: 1073-6085
Keywords: efficacy; vaccine; clinical trial
Academic Unit/Department: Mathematics, Computing and Technology > Mathematics and Statistics
Item ID: 22677
Depositing User: Sarah Frain
Date Deposited: 11 Aug 2010 11:00
Last Modified: 02 Dec 2010 21:02
URI: http://oro.open.ac.uk/id/eprint/22677
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