Clinical evaluation of new vaccines

Current effective version

PDF iconAdopted guideline

Currently under revision - see below

Reference numberEMEA/CHMP/VWP/164653/05
Published18/10/2006
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 PDF iconsummary of product characteristics requirements


Document history

Revision 1
In progress

PDF iconDraft guideline


PDF iconConcept paper

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

Published: 23/06/2017

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/02/2007–present


Published: 17/05/2005


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