Polio Infections and Infestations Polio
Conditions
Interventions
Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus Trivalent OPV (tOPV).
Measurements:
1. Cord blood will be collected immediately after birth
2. Blood collection at 30 days of age and stool c
Sponsors
Panacea Biotec Ltd (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy newborns (greater than or equal to 2.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9) at the study site(s) (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 2.75 kg 3. Apgar score at 5 minutes 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 after 30 days of a single dose of tOPV or mOPV1 produced for Biofarma bulk. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Prevalence of excretion of Poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 (age: 30 days + 7 days) 2. Comparison of mOPV1 produced by Biofarma bulk with the mOPV1 produced by Sanofi Pasteur bulk | — |
Countries
India
Outcome results
None listed