None listed
Conditions
Interventions
Intervention1: Intervention Arm 3: Rotavac â?? Rotasiil â?? Rotavac: Rotavac â?? Rotasiil â?? Rotavac
Intervention2: Intervention Arm 4: Rotasiil â?? Rotavac â?? Rotasiil: Rotasiil â?? Rotavac â?? Rot
Sponsors
Ministry of Health and Family Welfare
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy infants, as established by medical history and clinical examination before entering the study. 2. Age: 6-8 weeks at the time of enrollment. 3. Parental ability and willingness to provide informed consent. 4. Parent who intends to remain in the area with the child during the study period.
Exclusion criteria
Exclusion criteria: 1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion). 2. Presence of fever on the day of enrollment (temporary exclusion). 3. Acute disease at the time of enrollment (temporary exclusion). 4. Concurrent participation in another clinical trial throughout the entire timeframe for this study. 5. Presence of significant malnutrition (weight-for-height z-score 6. History of congenital abdominal disorders, intussusception or abdominal surgery 7. Known or suspected impairment of immunological function based on medical history and physical examination. 8. Prior receipt of rotavirus vaccine. 9. History of persistent diarrhea (defined as diarrhea more than 14 days). 10. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. 11. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 12. Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participantâ??s parents ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For examining the immunogenicity with respect to seroconversion, sera will be obtained immediately before the first vaccine dose and four weeks after the third dose and tested for rotavirus specific IgA antibodies using an enzyme-linked immunosorbent assay (ELISA) IgA assay. Quantitative ELISA, identifying a four-fold rise of rotavirus specific IgA from baseline, and above the cut-off of 20 IU/ml, will be defined as a positive seroresponse to the vaccination schedule.Timepoint: Sera will be compared between baseline (at recruitment at the age of 6-8 weeks) and 28 days after receipt of third dose of the vaccination schedule. | — |
Secondary
| Measure | Time frame |
|---|---|
| Surveillance for unsolicited AEs for each infant in the entire cohort will be carried out over the period between first vaccination and till 28 days after the third vaccination.Timepoint: Ongoing with vaccination, from enrolment till 28 days after third dose of vaccination. | — |
Countries
India
Contacts
Public ContactDr Suman Kanungo
ICMR-National Institute of Cholera and Enteric Diseases
Outcome results
None listed