A Randomized, Double-blind, Multicenter Phase II Trial to Compare the Immunogenicity and Safety of a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN) Smallpox Vaccine in Vaccinia-naive Healthy Subjects
Latest Information Update: 09 Jun 2024
At a glance
- Drugs Smallpox vaccine (Primary)
- Indications Smallpox
- Focus Pharmacodynamics
- Sponsors Bavarian Nordic
- 31 May 2024 According to a Bavarian Nordic media release, based on clinical data from a Phase 3 lot consistency study and data from a Phase 2 study, today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox disease in adults 18 years of age and older.
- 13 May 2015 Primary endpoint 'Geometric Mean Titers (GMTs) measured by ELISA' has been met, according to a Bavarian Nordic media release.
- 22 Sep 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.