Influenza vaccines - non-clinical and clinical module

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/VWP/457259/2014
Effective from01/02/2017
KeywordsInfluenza, guideline, pandemic, seasonal vaccine, strain change, immunogenicity, zoonotic vaccine
DescriptionThis module covers the requirements for non-clinical and clinical data to support an initial marketing authorisation for a seasonal, pandemic or zoonotic vaccine; requirements for strain change applications; recommendations for characterisation of the immune response and related immunogenicity issues; situations in which pre-authorisation clinical studies of protective efficacy and/or post-authorisation studies of vaccine effectiveness are required; pre-authorisation and post-authorisation safety data; risk management plan and summary of product characteristics aspects. The guidance is relevant to influenza vaccines that contain: live attenuated influenza viruses; inactivated split, subunit or whole virion viruses; adjuvants. However the general principles may be broadly applicable.

Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

Published: 29/07/2016


Published: 21/10/2016


Published: 31/07/2014


Published: 03/10/2011

Superseded document

Adopted guidelinePublished: 23/07/2009

Superseded document

Adopted guideline

Concept paper

Published: 20/02/2003

Published: 29/07/1999

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