UnknownPhase 4

Trial to Compare BCG-Bulgaria and BCG-Denmark

Guinea-Bissau15,000 participantsStarted 2022-10-21

Plain-language 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.

Who can participate

Age range0 Days – 1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

All-cause mortality risk

Timeframe: Six weeks of age

Trial details

NCT IDNCT05397678

SponsorBandim Health Project

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07

Contact for this trial

Peter Aaby, Professor

966620077 p.aaby@bandim.org

View on ClinicalTrials.gov More Death; Neonatal trials