None listed
Conditions
Interventions
Intervention1: Licensed monovalent oral rotavirus vaccine: Oral immunization with single dose of Rotarix at 6, 10, 14, 18 and 22 weeks
Control Intervention1: Licensed monovalent oral rotavirus vaccine
Sponsors
Christian Medical College
Eligibility
Inclusion criteria
Inclusion criteria: : Child Born after a gestational period of 36-42 weeks with birth weight >=2 kg; Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF) and available for follow up
Exclusion criteria
Exclusion criteria: : Child not meeting criteria for routine EPI immunization History of congenital abdominal disorders, intussusception, or abdominal surgery; Known or suspected impairment of immunological function; Known hypersensitivity to any component of the rotavirus vaccine; Prior receipt of any rotavirus vaccine; Fever, with axillary temperature >=38.1oC (>=100.5oF); measured by study staff. History of known rotavirus disease, chronic diarrhea, or failure to thrive; Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication); Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum anti-VP6 IgA at 4 weeks after the last dose of vaccineTimepoint: 4 weeks after the last dose of vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactRajeev Zachariah
Christian Medical College, Vellore
Outcome results
None listed