Influenza vaccines - non-clinical and clinical module - Scientific guideline
Table of contents
This 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.
Keywords: Influenza, guideline, pandemic, seasonal vaccine, strain change, immunogenicity, zoonotic vaccine
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Influenza vaccines - non-clinical and clinical module (PDF/325.36 KB)
Adopted
First published: 29/07/2016
Last updated: 29/07/2016
EMA/CHMP/VWP/457259/2014 -
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Overview of comments received on 'Draft guideline on influenza vaccines: non-clinical and clinical module ' (EMA/CHMP/VWP/457259/2014) (PDF/384.26 KB)
First published: 21/10/2016
Last updated: 21/10/2016 -
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Draft guideline on influenza vaccines: non-clinical and clinical module (PDF/302.99 KB)
Draft: consultation closed
First published: 31/07/2014
Last updated: 31/07/2014
Consultation dates: 31/07/2014 to 31/01/2015
EMA/CHMP/VWP/457259/2014 -
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Concept paper on the revision of guidelines for influenza vaccines (PDF/147.55 KB)
Draft: consultation closed
First published: 03/10/2011
Last updated: 03/10/2011
Consultation dates: 22/09/2011 to 31/12/2011
EMA/CHMP/VWP/734330/2011
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Core summary of product characteristics for pandemic-influenza vaccines - Superseded (PDF/51.58 KB)
Adopted
First published: 23/07/2009
Last updated: 23/07/2009
Legal effective date: 01/08/2009
EMEA/CHMP/VWP/193031/2004 Rev- 1 -
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Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on live attenuated influenza vaccines - Superseded (PDF/28.2 KB)
First published: 29/07/1999
Last updated: 29/07/1999
CPMP/BWP/1765/99 -
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Points to consider on the development of live attenuated influenza vaccines - Superseded (PDF/204.18 KB)
Adopted
First published: 20/02/2003
Last updated: 20/02/2003
Legal effective date: 31/08/2003
EMEA/CPMP/BWP/2289/01