Influenza vaccines - non-clinical and clinical module - Scientific guideline

This module covers the requirements for non-clinical and clinical data to support an initial marketing authorisation for a seasonal, pandemic or zoonotic vaccine; requirements for strain change applications; recommendations for characterisation of the immune response and related immunogenicity issues; situations in which pre-authorisation clinical studies of protective efficacy and/or post-authorisation studies of vaccine effectiveness are required; pre-authorisation and post-authorisation safety data; risk management plan and summary of product characteristics aspects. The guidance is relevant to influenza vaccines that contain: live attenuated influenza viruses; inactivated split, subunit or whole virion viruses; adjuvants. However the general principles may be broadly applicable.

Keywords: Influenza, guideline, pandemic, seasonal vaccine, strain change, immunogenicity, zoonotic vaccine