Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

Current effective version

PDF iconAdopted guideline

Reference number EMA/CHMP/VWP/141697/2009
Published 10/08/2010
Effective from 01/01/2011
Keywords Live recombinant viral vectored vaccine, heterologous antigen
Description This document provides recommendations on the quality, non-clinical and clinical studies that should be performed in order to obtain marketing authorisation of a live recombinant viral vectored vaccine intended for use in the prophylaxis of infectious disease in humans. Plasmid DNA vaccines, recombinant protein vaccines and vaccines against non-infectious indications, i.e. 'immunotherapeutic' medicinal products, are not within the scope of this guideline. Vaccines based upon bacterial vectors such as salmonella and Bacillus Calmette-Guérin are also not within the scope of this guideline, although many of the principles that apply here could also apply to these vaccines.

Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline


PDF icon Concept paper

In operation: 01/01/2011–present


Published: 20/04/2009


Published: 16/07/2007

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