Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority of Intradermal Fractional Inactivated Poliovirus Vaccine
- Conditions
- Poliomyelitis
- Registration Number
- NCT05460377
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Healthy infants 6 weeks of age (range: 42-48 days).<br><br> - Parents that consent for participation in the full length of the study (i.e., 34<br> weeks).<br><br> - Parents that are able to understand and comply with planned study procedures.<br><br>Exclusion Criteria:<br><br> - A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an<br> immediate family member.<br><br> - A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral<br> administration of sIPV or collection of blood by venepuncture.<br><br> - Acute diarrhoea, infection or illness at the time of enrollment (6 weeks of age)<br> that would require infant's admission to a hospital.<br><br> - Acute vomiting and intolerance to liquids within 24 hours before the enrollment<br> visit (6 weeks of age).<br><br> - Evidence of a chronic medical condition identified by a study medical officer during<br> physical exam.<br><br> - Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation<br> or parental recall.<br><br> - Known allergy/sensitivity or reaction to polio vaccine, or its contents.<br><br> - Infants from multiple births. Infants from multiple births will be excluded because<br> the infant(s) who is/are not enrolled would likely receive OPV through routine<br> immunization and transmit vaccine poliovirus to the enrolled infant.<br><br> - Infants from premature births (<37 weeks of gestation).
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaccine response
- Secondary Outcome Measures
Name Time Method Reciprocal antibody titers;Priming