Status:
COMPLETED
Comparing Morbidity and Mortality Effects of Two Different Strains of BCG
Lead Sponsor:
Bandim Health Project
Collaborating Sponsors:
Research Center for Vitamins and Vaccines
Conditions:
Heterologous Immunity
Infant Morbidity
Eligibility:
All Genders
Up to 42 years
Phase:
PHASE4
Brief Summary
Background: Investigators at Bandim Health Project (BHP, www.bandim.org) in Guinea-Bissau have shown in several randomized trials that the Bacille-Calmette-Guérin (BCG) vaccine against tuberculosis (T...
Detailed Description
In the trial, the investigators will compare the two currently most widely used BCG strains in the world, BCG-Russia and BCG-Japan, with respect to their non-specific effects on morbidity and mortalit...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Newborn, unvaccinated infants identified at the maternity ward and ready to be discharged
- Exclusion criteria:
- Infants above 6 weeks (\>42 days) of age; Infants with gross malformation; Infants that are acutely ill
Exclusion
Key Trial Info
Start Date :
October 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
17505 Patients enrolled
Trial Details
Trial ID
NCT03400878
Start Date
October 14 2017
End Date
October 1 2020
Last Update
December 16 2020
Active Locations (2)
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1
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
2
Bandim Health Project
Bissau, Guinea-Bissau