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Search / Trial NCT05397678

Trial to Compare BCG-Bulgaria and BCG-Denmark

Launched by BANDIM HEALTH PROJECT · May 26, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Bacillus Calmette Guérin Bcg Vaccine Non Specific Effects Of Bcg Heterologous Effects Maternal Immune Priming Maternal Bcg Scar

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.

About Bandim Health Project

The Bandim Health Project is a leading research initiative based in Guinea-Bissau, dedicated to improving public health outcomes through rigorous scientific investigation. Established in collaboration with local health authorities and international partners, the project focuses on a wide range of health issues, including disease prevention, maternal and child health, and infectious diseases. With a commitment to evidence-based practices, the Bandim Health Project conducts clinical trials and observational studies to inform healthcare policies and interventions, ultimately aiming to enhance health services and promote well-being in the region. Through its innovative research and community engagement, the project plays a crucial role in advancing global health knowledge and practices.

Locations

Bissau, , Guinea Bissau

Patients applied

0 patients applied

Trial Officials

Peter Aaby, Professor

Principal Investigator

Bandim Health Project

Christine Stabell Benn, Professor

Study Chair

University of Southern Denmark and Bandim Health Project

Frederik Schaltz-Buchholzer, MD, PhD

Study Director

University of Southern Denmark and Bandim Health Project

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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