Trial to Compare Two Strains of BCG (STRAIN III)
Death, Infant, Morbidity;Infant
About this trial
This is an interventional prevention trial for Death, Infant focused on measuring BCG vaccination, Non-specific effects of BCG, Heterologous effects, Maternal immune priming
Eligibility Criteria
Inclusion Criteria:
- Healthy infants present at the HNSM maternity ward on the day of discharge or procuring vaccination at the ward.
Exclusion Criteria:
- Infants older than 6 weeks (>42 days) of age
- Infants that have already received either BCG or oral polio vaccine (OPV)
- Infants that 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 may 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-Japan
BCG-Russia
Infants randomized to receive BCG-Japan at discharge from the Maternity Ward will receive one 0.05 ml dose of Mycobacterium bovis BCG live attenuated vaccine BCG-Japan (Tokyo BCG Laboratory) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG vaccination.
Infants randomized to receive BCG-Russia at discharge from the Maternity Ward will receive one 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine BCG-Russia-I (Serum Institute of India) by intradermal injection in the left deltoid region. Dependent on national supply, infants will receive oral polio vaccine (OPV) at the time of BCG-vaccination.