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

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.

Keywords: Live recombinant viral vectored vaccine, heterologous antigen