Trial to Compare BCG-Bulgaria and BCG-Denmark (BCGSTRAIN IV)
Death; Neonatal, Death, Infant, Morbidity;Newborn
About this trial
This is an interventional prevention trial for Death; Neonatal focused on measuring Bacillus Calmette-Guérin, BCG vaccine, Non-specific effects of BCG, Heterologous effects, Maternal immune priming, Maternal BCG scar
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.
Sites / Locations
- Bandim Health ProjectRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BCG-Denmark
BCG-Bulgaria
Infants randomized to receive BCG-Denmark at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-AJ vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.
Infants randomized to receive BCG-Bulgaria at discharge from the Maternity Ward will receive one 0.05 ml infant dose of Mycobacterium bovis BCG live-attenuated BCG-Bulgaria vaccine by intradermal injection in the left deltoid region. Dependent on national supply, oral polio vaccine will be co-administered.