Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00189969|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 21, 2006
|Condition or disease||Intervention/treatment||Phase|
|Smallpox||Biological: Elstree-BN||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||February 2006|
- Occurrence of a typical pock (“take”) which is associated historically with protection against variola within one week after vaccination.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189969
|Focus Clinical Drug Development GmbH|
|Neuss, Nordrhein, Germany, 41460|
|Principal Investigator:||Andreas Schroedter, M.D.||Focus Clinical Drug Development GmbH|