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Sponsors and Collaborators: |
University of Cape Town Aeras Global Tuberculosis Vaccine Foundation Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan. |
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Information provided by: | University of Cape Town |
ClinicalTrials.gov Identifier: | NCT00242047 |
An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.
Condition | Intervention | Phase |
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Tuberculosis |
Biological: Japanese (Tokyo) 172 Bacille Calmette Guerin (BCG). |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 12000 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | August 2006 |
This is an open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, obtained from the BCG laboratory in Tokyo, Japan, in the prevention of tuberculosis, with bacteriological or histological confirmation, or meeting strict clinical criteria, during the first two years of life. The comparison of the two methods is necessary because the intradermal method is almost universally preferred, without direct evidence from a clinical trial. The intradermal method provides for more accurate dosing and produces a higher rate of tuberculin skin test conversion, but neither of these factors has been shown to correlate with efficacy of BCG vaccination. The percutaneous method is much simpler and, if shown to be equally effective, could become a preferred method. The Japanese strain was chosen because it is the one commercially available strain produced for both intradermal and percutaneous administration, and because a seed lot from this strain was previously used to produce BCG for the South African BCG vaccination program.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa, Western Cape | |
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 Global Tuberculosis Vaccine Foundation |
Study ID Numbers: | UCT REC 271/2000 |
Study First Received: | October 18, 2005 |
Last Updated: | October 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00242047 |
Health Authority: | South Africa: Medicines Control Council |
Tuberculosis. Children. Vaccine. BCG. |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis |
Actinomycetales Infections |