Polio Infections and Infestations Polio
Conditions
Interventions
Control group: 2 drops (approximately 0.1 ml) standard dose tOPV manufactured by Panacea at birth and 30 days of age
Intervention group 1: 2 drops (approximately 0.1 ml) standard potency mOPV1 manufac
Sponsors
Panacea Biotec Limited (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9) 2. Born at study sites (maternity hospitals) 3. Residing less than 30 km away from study site 4. Not planning to travel during entire study period (birth to 2 months)
Exclusion criteria
Exclusion criteria: 1. Newborns requiring hospitalisation 2. Birth weight less than 2.5 kg 3. Apgar score at 5 minutes less than 9 4. Residence greater than 30 km from study sites 5. Families expecting to be absent during the 60 day study period 6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion 30 days after a single dose of tOPV or mOPV1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Seroconversion after two doses of vaccine (one of three mOPV1 vaccines and tOPV). | — |
Countries
India
Outcome results
None listed