MedTrace Logo

A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects

NCT00316524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 745

Last updated 2019-03-06

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

MVA-BN® (IMVAMUNE)

1x 10E8\_TCID50

BIOLOGICAL

Placebo

Tris-Buffer

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Frank von Sonnenburg, Prof · Section of International Medicine & Public Health, Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians Unviersity Munich

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-02-28
Completion
2007-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT00316524 on ClinicalTrials.gov