CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,005 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/NCT01144637
NCT01144637Phase 3Completed
CompareCT.gov

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

Bavarian Nordic·interventional·Posted Jun 15, 2010·Updated Jan 3, 2019

In Brief

A Phase 3 clinical trial evaluating IMVAMUNE® and Placebo for Smallpox. Completed, enrolled 4,005 participants across 34 sites.

Detailed 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.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2010
Enrollment StartFeb 1, 2013
Primary CompletionNov 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.0 years ago

Interventions

IMVAMUNE®biological

0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)

Placeboother

0.5 ml TBS