None listed
Conditions
Interventions
Intervention1: Injectable polio vaccine at 6 and 10 weeks of age: 90 children will receive injectable polio vaccine at 6 and 10 weeks, and oral polio vaccine at 14 weeks, in addition to the pentavale
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-rotavirus IgA in infants given two doses of Rotavirus with either oral polio vaccine or injectable polio vaccineTimepoint: At 14 weeks of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of Rotavirus IgA in infants with maternal IgA and IgGTimepoint: 0 and 14 weeks;Gut inflammatory markers - Alpha-1 Anti-Trypsin (AAT) and Myeloperoxidase (MPO) in stool.Timepoint: 6 and 14 weeks;Microbiota composition and diversity in infants who seroconvert and those who do notTimepoint: 0 and 14 weeks;Rotavirus sheddingTimepoint: 1 week after each dose of vaccine;Systemic inflammatory marker - Serum/Plasma acid glycoproteinTimepoint: 6 and 14 weeks | — |
Countries
India, Malawi, United Kingdom
Contacts
Public ContactDr Gagandeep Kang MD
Christian Medical College
Outcome results
None listed