EMEA: Draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

The objective of this guideline is to provide 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. This guideline is intended for products entering the marketing authorisation procedure. However, this principles laid down in the guideline should be considered by applicants entering into clinical trials.