NCT00857493

A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects

A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 56 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-Experienced Subjects

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	IMVAMUNE	Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose
BIOLOGICAL	IMVAMUNE	One s.c. vaccination with placebo (0.5 ml saline), followed by a second s.c. vaccination with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-03-06
• Last updated: 2019-01-10
• Results posted: 2019-01-10

Locations

4 sites across 1 country: United States