Trial to Compare BCG-Bulgaria and BCG-Denmark

Launched by BANDIM HEALTH PROJECT · May 26, 2022

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different strains of the BCG vaccine—one from Denmark and one from Bulgaria—to see which one is better for protecting infants from serious health issues and death. The study will involve 15,000 healthy infants under one year old at a hospital in Bissau, Guinea-Bissau, over two years. Researchers will look at how well each vaccine works, how it affects the infants during their hospital stay, and whether the mother's BCG vaccination status has any impact on the baby's health.

To participate, infants must be healthy and under one year old. However, those who have already received a BCG vaccine or an oral polio vaccine, or who are critically ill, will not be included. Families of participating infants can expect to have their child's health monitored closely during the trial, and the study aims to provide valuable insights that could improve health outcomes for babies in the future.

Gender

ALL

Eligibility criteria

• 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.