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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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.
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