CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
IMVAMUNE +1 morebiological
Likely dose
IMVAMUNE 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857493
NCT00857493Phase 2Completed
CompareCT.gov

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

Bavarian Nordic·interventional·Posted Mar 6, 2009·Updated Jan 10, 2019

In Brief

A Phase 2 clinical trial evaluating IMVAMUNE for Smallpox. Completed, enrolled 120 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.3 years ago

Interventions

IMVAMUNEbiological

Two s.c. vaccinations with 0.5 ml IMVAMUNE® vaccine containing 1 x 10E8 TCID50 / dose

IMVAMUNEbiological

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