Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
|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)|
|Estimated 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|
|Estimated 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.
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|