Poliomyelitis Infections and Infestations Poliomyelitis
Conditions
Interventions
Control group:
2 drops (approximately 0.1 ml) standard dose of tOPV manufactured by GlaxoSmithKline (GSK) at birth.
Intervention groups:
1. 2 drops (approximately 0.1 ml) of mOPV1 manufactured by GSK
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants (birth weight greater than or equal to 2.5 kg and Apgar score greater than or equal to 9 at 5 minutes) born at study sites 2. Residing less than or equal to 50 km from study sites 3. Family is not planning on travel during the study period (birth to 1 month)
Exclusion criteria
Exclusion criteria: 1. High risk newborns 2. Other newborns requiring hospitalisation 3. Birthweight less than 2.5 kg 4. Apgar score less than 9 at 5 minutes 5. Infants residing more than 50 km from study sites 6. Infants whose families are planning to be absent during one month study period 7. A diagnosis or suspicion of B cell immunodeficiency in participant or immediate family The study will not collect information on acquired immunodefiency disease or Human Immunodeficiency Virus (HIV) status of mother or study subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion 30 days after a single dose of tOPV, mOPV1, or mOPV3. Measurements on humoral immunity (specific primary endpoints) as as follows: 1. One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than one dose of tOPV 2. One dose of mOPV3 induces significantly higher levels of seroconversion against poliovirus type 3 than one dose of tOPV | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
South Africa
Outcome results
None listed