NCT00316524

A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects

A Partially Randomized, Partially Double-blind, Placebo-controlled Phase II Non-inferiority Study to Evaluate Immunogenicity and Safety of One and Two Doses of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in 18-55 Year Old Healthy Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 745 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects. In addition the study further investigates the cardiac safety profile of MVA-BN® in a healthy population compared to placebo.

Detailed description

The study consists of 4 groups, which receive either MVA-BN once, MVA-BN two times, MVA-BN followed by placebo, or two administrations of placebo.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	MVA-BN® (IMVAMUNE)	1x 10E8\_TCID50
BIOLOGICAL	Placebo	Tris-Buffer

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-02-01
• Completion: 2007-08-01
• First posted: 2006-04-21
• Last updated: 2019-03-06
• Results posted: 2019-01-09

Locations

1 site across 1 country: Germany