A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older
Phase of Trial: Phase III
Latest Information Update: 24 Nov 2015
At a glance
- Drugs Influenza virus vaccine (Primary) ; MF 59
- Indications Influenza virus infections
- Focus Pharmacodynamics; Registrational; Therapeutic Use
- Sponsors Novartis Vaccines
- 24 Nov 2015 According to FDA media release, Fluad was approved by U.S. FDA using the accelerated approval regulatory pathway for the prevention of seasonal influenza in people of 65 years of age and older.
- 15 Sep 2015 Results were published in a CSL media release.
- 15 Sep 2015 According to a CSL media release, based on results of this study the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US FDA has voted to recommend licensure of influenza vaccine FLUAD to help protect against seasonal influenza in those aged 65 years and older via accelerated approval.