Issue Date: May 31, 2007
Issued by: Center for Biologics Evaluation and Research
Topic(s): Vaccines
Status: Final
Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for Industry
This document is intended to provide to you, sponsors of seasonal inactivated influenza vaccines, guidance on clinical development approaches to support a Biologics License Application (BLA). The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based seasonal vaccines, including “split virus,” subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. This document does not address live attenuated influenza vaccines or influenza vaccines that do not rely on immunity to a hemagglutinin component.
Download the Guidance Document
