Status:
COMPLETED
Trial to Compare Two Strains of BCG
Lead Sponsor:
Bandim Health Project
Collaborating Sponsors:
University of Southern Denmark
Conditions:
Death, Infant
Morbidity;Infant
Eligibility:
All Genders
Up to 42 years
Phase:
PHASE4
Brief Summary
The trial will be a two-year outcome assessor-blinded RCT at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 infa...
Detailed Description
This two-year outcome assessor-blinded RCT will be conducted at the maternity ward of hospital Simão Mendes (HNSM) in urban Bissau, Guinea-Bissau to compare BCG-Japan versus BCG-Russia 1:1 in 15,000 i...
Eligibility Criteria
Inclusion
- Healthy infants present at the HNSM maternity ward on the day of discharge or procuring vaccination at the ward.
Exclusion
- Infants older than 6 weeks (\>42 days) of age
- Infants that have already received either BCG or oral polio vaccine (OPV)
- Infants that are moribund due to gross malformation or acute illness (about to die or be transferred to the pediatric ward according to the local health physician assessment; the latter children may be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit).
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
16390 Patients enrolled
Trial Details
Trial ID
NCT04383925
Start Date
May 4 2020
End Date
December 1 2022
Last Update
January 22 2024
Active Locations (1)
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1
Bandim Health Project
Bissau, Guinea-Bissau