A study on the maternal and infant factors determining the performance of Rotavirus vaccines in African, Indian and European infants.
Phase 4
- Registration Number
- CTRI/2015/11/006354
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 385
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
a) Mothers willing to consent before the baby is born.
b) Babies born full-term with no evident congenital abnormalities or neonatal complications.
c) Families planning to administer rotavirus vaccine per IAP recommended schedule
Exclusion Criteria
The subjects will be excluded from the study under the following circumstances:
a) Parent or guardian does not consent or is not available to give the consent.
b) Mother with a known prior diagnosis of congenital immune deficiency, chronic renal or liver failure or other chronic illness which may affect the immune response.
c) Residence outside Vellore.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method