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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top