Effect of Inactivated Poliovirus Vaccine (IPV) on Mucosal Immunity: A Randomized, Controlled Trial in Cuba
- Conditions
- PoliomyelitisInfection - Other infectious diseases
- Registration Number
- ACTRN12623001320640
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 400
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method