Role of oral and inactivated poliovitus vaccines in inducing mucosal immunity - a trial in small children in Cuba

• Conditions: poliomyelitis; Infection - Other infectious diseases; Public Health - Epidemiology

• Registration Number: ACTRN12616000169448
• Lead Sponsor: WHO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Healthy infants born between June 1 and August 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arms 1 and 2.
Healthy infants born between November 1 and December 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arm 3.

Exclusion Criteria

Infants <3 percentile for height and weight, residence outside the catchment’s area, or families expecting to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the child ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally incapacity will not be eligible to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference in poliovirus shedding in stool [7 days after tOPV dose]

Secondary Outcome Measures

Name	Time	Method
difference in dynamic of poliovirus shedding after tOPV dose assessed by virus isolation in stool on days 14, 21 and 42 after tOPV dose[14, 21 and 42 days after tOPV challenge]