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A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

NCT01144637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4005

Last updated 2019-01-03

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

IMVAMUNE®

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

OTHER

Placebo

0.5 ml TBS

Sponsors & Collaborators

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Turner Overton, MD · Division of Infectious Diseases University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-11-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144637 on ClinicalTrials.gov