Evaluation of Mucosal Immunity to Polioviruses Following Administration of Polio Vaccines in Pakista
Phase 4
Recruiting
- Conditions
- poliomyelitisInfection - Other infectious diseasesPublic Health - Other public health
- Registration Number
- ACTRN12612000264886
- Lead Sponsor
- WHO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1485
Inclusion Criteria
Healthy children aged 6-11 months, 5-6 years or 10-11-years, that reside within a relatively short and easily accessible distance (<30 km) to the study sites, and do not plan to travel away during entire the study period
Exclusion Criteria
Children with known thrombocytopenia or bleeding disorders; children acutely ill or with signs of acute infection (e.g. fever > 101 F) at the time of enrolment; residence >30 km from study site; or families expecting to be absent during the 60-day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will also render the child ineligible for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in excretion of a challenge dose of vaccine poliovirus administered 28 days after a single dose of bOPV or IPV following a challenge dose with bOPV, compared to an unvaccinated control arm. This outcome is assessed by comparision of viral shedding in stool of enrolled children.[Day 28 of study]
- Secondary Outcome Measures
Name Time Method Increase of sIgA in gingival fluids and stools 28 days after a dose of bOPV or IPV.[Day 28 of study];Increase in poliovirus antibody secreting cells (measured with ELISPOT) 7 days following a dose of bOPV or IPV.[Day 7 of study];Seroconversion or antibody titre boosting 28 days following a single dose of bOPV or IPV.[Day 28 of study]