Impact of IPV on mucosal immunity: A randomized controlled trial comparing nasopharyngeal and intestinal poliovirus shedding after bOPV challenge in IPV recipients with those not receiving IPV

World Health Organization0 sites400 target enrollmentDecember 15, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Healthy infants born June\-August 2023 (i.e, 6\-8 months of age at time of enrolment in February 2024\) residing in Camaguey province of Cuba
•2\.Over the 3rd percentile for height and weight
•3\.Resident of the study locality for more than or at least 5 months, with no plans to move
•4\.Previously received one dose of fIPV in primary series at 4 months of age
•5\.Parent/guardian consent for participation in the study and for samples collection

•1\.Infant not fulfilling inclusion criteria
•2\.Contraindication for venepuncture
•3\.Having received bOPV or 2nd fIPV dose before enrolment
•4\.Acutely sick child or child requiring hospitalization. These children will be referred to the nearest medical facility equipped to handle the case at their own expense.
•5\.Diagnosis or suspicion in the subject or an immediate family member of congenital medical conditions (e.g., Down Syndrome); primary immunodeficiency disorder; chronic medical illness (e.g., renal, cardiac)
•6\.Infants of mothers below the legal age (\<18 years) or with mental incapacity will not be eligible to participate.