Polio Infections and Infestations Polio
Conditions
Interventions
One dose of monovalent oral poliovirus vaccine compared to trivalent oral poliovirus vaccine.
Measurements:
1. Cord blood will be collected immediately after birth
2. 30 days after birth, second samp
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants born healthy (greater than or equal to 2.75 kg, apgar score greater than or equal to 9 at five minutes) at the study site(s) (large maternity hospitals) 2. Residing within a relatively short and easily accessible distance (less than 30 km) in the same governorate as the study site 3. Not planning to travel away during entire the study period (birth to two months)
Exclusion criteria
Exclusion criteria: 1. High-risk newborns will be excluded 2. Newborns requiring hospitalisation 3. Birth weight below 2.75 kg 4. Apgar score less than 9 at five minutes 5. Residence greater than 30 km from study site (or residing in another governorate) 6. Family is planning to be absent during the 60-day study period 7. 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 |
|---|---|
| To demonstrate the superiority of one dose of mOPV1 compared with tOPV by assessing: 1. Humoral Immunity - one dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than does one dose of tOPV 2. Mucosal Immunity - one dose of mOPV1 significantly reduces excretion of poliovirus type 1 after a mOVP1 challenge than following one dose of tOPV | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is prevalence of excretion of poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 at age 30 days + 7 days. Additional endpoints will be prevalence of excretion in 4 weeks after mOPV1 challenge by vaccination group; and seroconversion at 60 days after 2 doses of mOPV1 (no control available). | — |
Countries
Egypt
Outcome results
None listed