Comparing two types of BCG vaccines for infants
Randomized Trial Evaluating the Non-specific Effects of BCG-Bulgaria and BCG-Denmark in Guinea-Bissau: Effects on Mortality, Morbidity, and BCG Skin Reactions
This study is testing which of two BCG vaccine types is better for keeping infants healthy and reducing deaths in babies under one year old.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 15000 (estimated) |
| Ages | 0 Days to 1 Year |
| Sex | All |
| Sponsor | Bandim Health Project Academic / other |
| Locations | 1 site (Bissau) |
| Trial ID | NCT05397678 on ClinicalTrials.gov |
What this trial studies
This trial is a two-year randomized controlled trial conducted at the maternity ward of Hospital Simão Mendes in Bissau, Guinea-Bissau, aiming to compare the effects of two BCG vaccine strains, BCG-Denmark and BCG-Bulgaria, on infant mortality and morbidity. The study will enroll 15,000 healthy infants under one year of age and assess outcomes such as mortality rates and case-fatality rates during hospital admissions. Additionally, it will explore the relationship between maternal BCG vaccination status and infant health outcomes, as well as the characteristics of skin reactions to the vaccines.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants under one year of age who are vaccinated at the HNSM maternity ward.
Not a fit: Infants who have already received either BCG or oral polio vaccine, or those who are critically ill, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vaccination strategies that significantly reduce infant mortality and morbidity.
How similar studies have performed: Previous studies have indicated potential benefits of different BCG strains, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bissau
- Bandim Health Project — Bissau, Guinea-Bissau (Recruiting)
Study contacts
- Principal investigator: Peter Aaby, Professor — Bandim Health Project
- Study coordinator: Peter Aaby, Professor
- Email: p.aaby@bandim.org
- Phone: 966620077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.