Adjuvants in vaccines for human use

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Current effective version

Adopted guideline

Reference numberCHMP/VEG/134716/04
Published20/01/2005
Effective from31/07/2005
KeywordsImmunomodulators, adjuvants, vaccines
DescriptionThis 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


Document history

First version

Current version

Adopted guideline


Concept paper

In operation: 31/07/2005–present


Published: 25/04/2002


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