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Assessing vaccine efficacy in influenza clinical trials: challenges and difficulties

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Dewe, Walthere [GlaxoSmithKline] Benoît, Anne [UCL] Legrand, Catherine [UCL]

The efficacy assessment of an influenza vaccine often requires conducting large and expensive clinical trials. Specificities of influenza increase the complexity of the study designs, of the subsequent statistical analysis and of the interpretation of the results. They include low attack rates, seasonality, multiplicity and frequent mutations of flu viruses as well as heterogeneity of virus circulation, varying annual vaccine composition and so on. The authors discuss how those factors may impact the design, the conduct and the analysis of an efficacy trial and explain why it may fail whatever the true vaccine efficacy. The authors then argue that extending the length to several consecutive seasons is an alternative to the frequently used 1-year design and propose refinements of the statistical models.

Document type Article de périodique (Journal article) – Article de recherche
Publication date 2013
Language Anglais
Journal information "Expert Review of Clinical Pharmacology" - Vol. 6, no.4, p. 403-411 (2013)
Peer reviewed yes
Publisher Expert Reviews Ltd. ((United Kingdom) London)
issn 1751-2433
e-issn 1751-2441
Publication status Publié
Affiliation UCL - SSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles
Links
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Bibliographic reference Dewe, Walthere ; Benoît, Anne ; Legrand, Catherine. Assessing vaccine efficacy in influenza clinical trials: challenges and difficulties. In: Expert Review of Clinical Pharmacology, Vol. 6, no.4, p. 403-411 (2013)
Permanent URL http://hdl.handle.net/2078.1/135891