Comparison trial of three needle-free devices for application of intradermal inactivated polio vaccine in young infants in Cuba
Phase 3
- Conditions
- poliomyelitisInfection - Other infectious diseasesPublic Health - Epidemiology
- Registration Number
- ACTRN12612000482864
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Healthy infants born between July 1 and December 31, 2011 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers with documented history of receiving two doses of OPV through NIDs in 2012.
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 newborn 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 The primary endpoint is seroconversion or boost of polio antibodies by neutralization assay on day 28 compared to day 0[Day 28 from enrollment]
- Secondary Outcome Measures
Name Time Method Seroconversion or boost of antibodies by neutralization assay on days 3 and 7.[Day 3 and Day 7 from enrollment];Assessment of priming immune response after the first dose of IPV by neutralization assay.[Day 7 from enrollment]