Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
|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: NCT00242047|
Recruitment Status : Unknown
Verified November 2004 by University of Cape Town.
Recruitment status was: Active, not recruiting
First Posted : October 19, 2005
Last Update Posted : October 19, 2005
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG).||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled Trial Comparing Efficacy of Percutaneous and Intradermal Vaccination With Japanese (Tokyo) 172 BCG in the Prevention of Tuberculosis In Infants Vaccinated at Birth|
|Study Start Date :||March 2001|
|Study Completion Date :||August 2006|
- Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life.
- Comparison of Rate of Adverse Events.
- Comparison of Mortality Rates.
- Microbiological diagnosis of tuberculosis in a primary care setting.
- Rating of diagnostic scoring systems.
- Case definition of tuberculosis.
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): NCT00242047
|South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.|
|Cape Town, Western Cape, South Africa, 7925|
|Principal Investigator:||Gregory Hussey, FCCH||South African Tuberculosis Vaccine Initiative|
|Principal Investigator:||Larry Geiter, PhD||Aeras|