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

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Smallpox
Interventions
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

Trial Locations (4)

16462

University of Rochester, Medical Center, Rochester

32809

Orlando Clinical Research Center, Orlando

52242

University of Iowa, Iowa City

40536-0084

University of Kentucky, School of Medicine, Department of Medicine, Lexington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bavarian Nordic

INDUSTRY