Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: April 20, 2006
Last verified: April 2006
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Study to Evaluate Take Rate, Immunogenicity and Safety of Bavarian Nordic’s Smallpox Vaccine Elstree-BN Administered to Healthy Vaccinia-Naive Subjects in the Age of 18-32 Years|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Bavarian Nordic:
Primary Outcome Measures:
- Occurrence of a typical pock (“take”) which is associated historically with protection against variola within one week after vaccination.
Secondary Outcome Measures:
- Occurrence, relationship and intensity of any serious adverse event at any time during the study / any non-serious adverse event within 4 weeks after vaccination.
- ELISA / Neutralisation assay specific seroconversion rates and geometric mean titres 2,4,12,52 and 104 weeks after vaccination.
- Interferone-gamma producing T cells 2,4,12,52 and 104 weeks after vaccination.
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||February 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189969
|Focus Clinical Drug Development GmbH|
|Neuss, Nordrhein, Germany, 41460|
Sponsors and Collaborators
|Principal Investigator:||Andreas Schroedter, M.D.||Focus Clinical Drug Development GmbH|