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Vaccine evaluation: efficacy and adverse events 

Vaccine evaluation: efficacy and adverse events
Chapter:
Vaccine evaluation: efficacy and adverse events
Author(s):

Laura C. Rodrigues

DOI:
10.1093/med/9780198719830.003.0012
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date: 20 February 2020

The protection offered by vaccines is a key part of the control of infectious diseases. As active immunogenic products, vaccines may cause adverse reactions. This chapter describes the concepts and methods used to evaluate the efficacy and adverse events associated with vaccines. Topics covered include the evaluation of vaccine protection (direct and indirect), measurements of efficacy (efficacy against different outcomes, efficacy against non-specific outcomes, correlates of protection, bridging studies, all-or-nothing versus partial protection models, efficacy against infectiousness, and study design and methodological issues), and adverse events (generating and testing hypotheses, measurements of frequency of adverse events, study designs, and methodological issues).

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