Clinical evaluation of new vaccines

  • Email
  • Help
Current effective version

Adopted 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 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


Related content


How helpful is this page?

Average rating:

 Based on 47 ratings

Add your rating:

See all ratings
9 ratings
9 ratings
10 ratings
10 ratings
9 ratings
    

Tell us more