At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 745 enrolled

Drug / intervention

MVA-BN® (IMVAMUNE) +1 morebiological

Likely dose

Not stated in 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/NCT00316524

NCT00316524Phase 2Completed

Compare CT.gov

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

Bavarian Nordic·interventional·Posted Apr 21, 2006·Updated Mar 6, 2019

In Brief

A Phase 2 clinical trial evaluating MVA-BN® (IMVAMUNE) and Placebo for Smallpox. Completed, enrolled 745 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSmallpox

CountriesGermany

CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2006

First PostedApr 2006

Primary CompletionFeb 2007

Study CompletionAug 2007

TodayJul 2026

First PostedApr 21, 2006

Enrollment StartApr 1, 2006

Primary CompletionFeb 1, 2007

Study CompletionAug 1, 2007

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 20.2 years ago

Interventions

MVA-BN® (IMVAMUNE)biological

1x 10E8\_TCID50

Placebobiological

Tris-Buffer