A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE (MVA-BN) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects.
Phase of Trial: Phase III
Latest Information Update: 06 Feb 2018
At a glance
- Drugs Smallpox vaccine (Primary)
- Indications Smallpox
- Focus Registrational; Therapeutic Use
- Sponsors Bavarian Nordic
- 06 Feb 2018 According to a Bavarian Nordic media release, the company plans to file a Biological License Application in the second half of 2018 with fast track designation.
- 13 May 2015 According to a Bavarian Nordic media release, based on the results of this trial liquid-frozen formulation of smallpox-vaccine (IMVAMUNE) supporting a Biologics License Application for U.S. approval of vaccine.
- 13 May 2015 Primary endpoint 'Geometric Mean Titers (GMTs) measured by PRNT' has been met, according to a Bavarian Nordic media release.