Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
This study has been completed.
Information provided by:
First received: September 11, 2005
Last updated: October 10, 2006
Last verified: October 2006
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Open-Label, Controlled Phase I Pilot Study to Evaluate Safety and Immunogenicity of MVA-BN® Smallpox Vaccine in 18-40 Year Old Vaccinia-naïve Subjects With Atopic Disorders|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Bavarian Nordic:
Primary Outcome Measures:
- Occurrence, relationship and intensity of any serious adverse event at any time during the study.
Secondary Outcome Measures:
- ELISA specific seroconversion rates and geometric mean titres (at all blood sampling time points).
- Neutralisation assay specific seroconversion rates and geometric mean titres (at all blood sampling time points).
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||April 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189917
|Department of Infectious Diseases and Tropical Medicine|
|Munich, Bavaria, Germany, 80802|
Sponsors and Collaborators
|Principal Investigator:||Frank von Sonnenburg, M.D.||Department of Infectious Diseases and Tropical Medicine of the University of Munich|