Adjuvants in vaccines for human use - Scientific guideline
Table of contents
This document addresses the quality, non-clinical and clinical issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on case-by-case basis. Adjuvants that are given separately and/or at a different time point from the vaccine antigens are not considered to be adjuvants and are called immunomodulators. Read together with the
Explanatory note on immunomodulators
Keywords: Immunomodulators, adjuvants, vaccines
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Guideline on adjuvants in vaccines for human use (see also explanatory note) (PDF/187.04 KB)
Adopted
First published: 20/01/2005
Last updated: 20/01/2005
Legal effective date: 31/07/2005
EMEA/CHMP/VEG/134716/2004 -
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Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on requirements for the evaluation of new adjuvants in vaccines (PDF/122.19 KB)
First published: 25/04/2002
Last updated: 25/04/2002
CPMP/BWP/6622/02 -
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Draft guideline on adjuvants in vaccines (PDF/205.95 KB)
First published: 25/03/2004
Last updated: 25/03/2004
Legal effective date: 25/03/2004
EMEA/CPMP/VEG/17/03/2004v 5/Consultation