Poliomyelitis Infections and Infestations Other viral encephalitis, not elsewhere classified
Conditions
Interventions
1. Control: standard trivalent oral poliovirus vaccine (tOPV) - one or two doses
2. Intervention group one: monovalent type 1 oral poliovirus vaccine (mOPV1) - one or two doses
3. Intervention group
Sponsors
Panacea Biotec Limited (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy newborns (either sex) (greater than or equal to 2.50 kg birth weight, apgar score at 5 min greater than or equal to 9) at the study sites (large maternity hospitals) 2. Residing within a relatively short and easily accessible distance (less than 30 km) 3. Not planning to travel away during entire the study period (birth - 2 months)
Exclusion criteria
Exclusion criteria: 1. Newborns requiring hospitalisation 2. Birth weight below 2.50 kg 3. Apgar score at 5 min less than 9 4. Residence greater than 30 km from study site 5. Families expecting to be absent during the 60-day study period 6. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion 30 days after a single dose of mOPV2 or mOPV3 compared to tOPV or seroconversion following a single dose of bOPV compared to mOPV1. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Seroconversion of two doses of mOPV2 or mOPV3 compared to tOPV 2. Seroconversion of one or two doses of bOPV compared to mOPV1 or mOPV3 3. Prevalence of excretion of poliovirus serotypes 1, 2, and 3 at 7, 30, 37, and 60 days (at Indore site only) | — |
Countries
India
Outcome results
None listed