Farrington, C. P. and Miller, E.
|DOI (Digital Object Identifier) Link:||http://doi.org/10.1385/MB:17:1:43|
|Google Scholar:||Look up in Google Scholar|
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.|
|Keywords:||efficacy; vaccine; clinical trial|
|Academic Unit/Department:||Mathematics, Computing and Technology > Mathematics and Statistics
Mathematics, Computing and Technology
|Depositing User:||Sarah Frain|
|Date Deposited:||11 Aug 2010 11:00|
|Last Modified:||15 Jan 2016 14:47|
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