NCT01144637

A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,005 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	IMVAMUNE®	0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
OTHER	Placebo	0.5 ml TBS

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-11-01
• Completion: 2014-06-01
• First posted: 2010-06-15
• Last updated: 2019-01-03
• Results posted: 2019-01-03

Locations

34 sites across 1 country: United States