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

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/VWP/141697/2009
Effective from01/01/2011
KeywordsLive recombinant viral vectored vaccine, heterologous antigen
DescriptionThis 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

Adopted guideline

Draft guideline

Concept paper

In operation: 01/01/2011–present

Published: 20/04/2009

Published: 16/07/2007

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