Comparison of boosting of mucosal immunity after full and fractional dose of inactivated poliovirus vaccine, clinical trial in children in Sri Lanka, 2016

• Conditions: poliomyelitis; Infection - Other infectious diseases

• Registration Number: ACTRN12616000124437
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Any child 10-12 years of age residing in the determined area of Kalutara
Parent/Guardian provides consent for child’s participation, including vaccination with IPV/OPV and blood and stool sample collections

Exclusion Criteria

Contraindication for venepuncture
Sick child requiring hospitalization for acute or chronic condition
Diagnosis or suspicion of congenital immunodeficiency disorder in the subject or an immediate family member

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in proportion of children excreting vaccine polioviruses (by serotype) between arms among those who serologically respond to IPV measured by isolation of poliovirus in stool[7 days after administration of live oral poliovirus vaccine]

Secondary Outcome Measures

Name	Time	Method
Difference in duration of poliovirus excretion between arms measured by isolation of poliovirus in stool[42 days after challenge with oral poliovirus vaccine]