Tuberculosis Clinical Trial
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
Verified date | November 2004 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 12000 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 24 Hours |
Eligibility |
Inclusion Criteria: 1. The child must be eligible to receive routine BCG vaccination. 2. The child must be born at one of the five hospitals taking part in the study and be a resident in the study area. 3. The mother must have had an opportunity to become informed about the study, either through pre-natal classes and a follow-up visit or, if time and the situation permits, after the mother presents at the hospital or birthing facility and before or after the child is born. 4. After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form. Exclusion Criteria: 1. The mother fails to give informed consent. 2. The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams). 3. The infant is hospitalized outside of the study area before vaccination has been given (e.g. transferred to a hospital in Cape Town because of respiratory distress). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town. | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Aeras, Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan. |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevention of tuberculosis with bacteriological or histological confirmation, or meeting strict clinical criteria,in the first 2 years of life. | |||
Secondary | Comparison of Rate of Adverse Events. | |||
Secondary | Comparison of Mortality Rates. | |||
Secondary | Microbiological diagnosis of tuberculosis in a primary care setting. | |||
Secondary | Rating of diagnostic scoring systems. | |||
Secondary | Case definition of tuberculosis. |
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