Clinical evaluation of new vaccines

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Current effective version

Adopted guideline

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 thesummary of product characteristics requirements

Document history

Revision 1Concept paper

Published: 23/06/2017


Deadline for comments: 30/09/2017

First version

Current version

Adopted guideline

Draft guideline

In operation: 01/02/2007–present

Published: 17/05/2005

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