Trial Profile
A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN Smallpox Vaccine in Healthy, Vaccinia-naive Subjects
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Dec 2022
Price :
$35
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At a glance
- Drugs Smallpox vaccine (Primary)
- Indications Smallpox
- Focus Pharmacodynamics; Registrational
- Sponsors Bavarian Nordic
- 29 Nov 2022 Results assessing the immunogenicity and safety of 3 consecutively produced lots of freeze-dried MVA-BN vaccine in healthy adults, published in the Vaccine.
- 24 Aug 2020 According to a Bavarian Nordic media release, the completion of this study will enable the Company to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN. The extension would cover both the smallpox and the monkeypox indication.
- 24 Aug 2020 Primary endpoint (Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titres) has been met, according to a Bavarian Nordic media release.