Status:
RECRUITING
Trial to Compare BCG-Bulgaria and BCG-Denmark
Lead Sponsor:
Bandim Health Project
Collaborating Sponsors:
University of Southern Denmark
Conditions:
Death; Neonatal
Death, Infant
Eligibility:
All Genders
Up to 1 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 vaccination with Bacillus Calmette-Guérin (BCG...
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-Denmark versus BCG-Bulgaria 1:1 in 15,0...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Healthy infants under one year of age who are vaccinated at the HNSM maternity ward.
- Exclusion criteria:
- Infants who have already received either BCG or oral polio vaccine (OPV)
- Infants who 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 can be recruited when they are discharged from the pediatric ward or the neonatal intensive care unit.
Exclusion
Key Trial Info
Start Date :
October 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
15000 Patients enrolled
Trial Details
Trial ID
NCT05397678
Start Date
October 21 2022
End Date
October 1 2024
Last Update
January 22 2024
Active Locations (1)
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1
Bandim Health Project
Bissau, Guinea-Bissau