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drugset / Trial / NCT05397678

Trial to Compare BCG-Bulgaria and BCG-Denmark

NCT05397678 ↗

Phase 4 Unknown 15000 enrolled Bandim Health Project University of Southern Denmark · collab
RandomizedParallel-groupDouble-blindPrevention

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) Danish strain (AJ Vaccines, Copenhagen 1331 strain) versus BCG-Bulgaria (BB-NCIPD, BCG-SL 222 Sofia strain) 1:1 in 15,000 infants with respect to mortality, morbidity and case-fatality rate during hospital admission. The trial will also examine the association between BCG strains and BCG skin reaction kinetics and characteristics. As a secondary aim, this large study will be used to further evaluate the role of maternal BCG immune priming for overall health, since there are indications that the maternal BCG scar status influences offspring health outcomes.

Timeline

Start
2022-10-21
Primary completion
2024-07
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG vaccine Vaccine 0.05 ml Other
Comparator BCG-Bulgaria Vaccine 0.05 ml Other

Indications

No indication recorded.