Clinical evaluation of new vaccines

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Current effective version

Adopted guideline

Currently under revision - see below

Reference numberEMEA/CHMP/VWP/164653/05
Effective from01/02/2007
KeywordsVaccines, humoral immune response, cellular immune response, vaccination schedule, immunogeicity studies, protective efficacy, effectiveness, safety, summary of product characteristics (SmPC) requirements
DescriptionThis document covers the clinical evaluation of vaccines for pre- and post-exposure prophylaxis against infectious diseases. It is primarily intended to assist applicants and competent authorities to design, and evaluate data from, appropriate clinical development programmes. It addresses studies to be performed during the clinical development of new vaccines. Read together with the summary of product characteristics requirements

Document history

Revision 1
In progress

Draft guideline


Concept paper

Published: 26/04/2018
Deadline for comments: 30/10/2018


Published: 23/06/2017

First version

Current version

Adopted guideline

Draft guideline

In operation: 01/02/2007–present

Published: 17/05/2005

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