Status:
UNKNOWN
Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Aeras
Japan BCG Laboratory 4-2-6 Kohinata,Tokyo 112-0006, Japan.
Conditions:
Tuberculosis
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE4
Brief Summary
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, i...
Detailed Description
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) 17...
Eligibility Criteria
Inclusion
- The child must be eligible to receive routine BCG vaccination.
- The child must be born at one of the five hospitals taking part in the study and be a resident in the study area.
- 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.
- After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form.
Exclusion
- The mother fails to give informed consent.
- The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams).
- 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).
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
12000 Patients enrolled
Trial Details
Trial ID
NCT00242047
Start Date
March 1 2001
End Date
August 1 2006
Last Update
October 19 2005
Active Locations (1)
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1
South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, University of Cape Town.
Cape Town, Western Cape, South Africa, 7925