None listed
Conditions
Interventions
Intervention1: ROTAVAC®: 0.5mL single dose containing NLT 105.0ffu of live rotavirus 116E. ROTAVAC® is administered as three doses at4 (+1) weeks interval starting at 6-8 weeks of age.
The vaccine i
Sponsors
Bharat biotech International Limited
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 3. Weight >=2.5 kgs at birth. 4. Infants received age-appropriate UIP vaccines till enrolment and during the study. 5. Parental ability and willingness to provide informed consent. 6. Parent who intends to remain in the area with the subject during the study period
Exclusion criteria
Exclusion criteria: 1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion). 2. Presence of fever on the day of enrolment (temporary exclusion). 3. Concurrent participation in another clinical trial. 4. Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the childâ??s health or is likely to result in non-conformance to the protocol. 5. History of congenital abdominal disorders, intussusception, abdominal surgery 6. Known or suspected impairment of immunological function based on medical history and physical examination. 7. Household contact with an immunosuppressed individual or pregnant woman. 8. Prior receipt of rotavirus vaccine. 9. A known sensitivity or allergy to any components of the study vaccines. 10. Major congenital or genetic defect. 11. History of persistent diarrhea (defined as diarrhea more than 14 days). 12. Subjectâ??s parents not able, available or willing to accept active follow-up by the study staff. 13. Has received any immunoglobulin therapy and/or blood products since birth. 14. History of chronic administration (defined as more than 14 days) of immunosuppressantâ??s including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 15. History of any neurologic disorders or seizures. 16. Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a subjectâ??s parentâ??s/legally acceptable representativeâ??s ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in immunogenicity (GMTs) achieved with ROTAVAC® , when administered orally as 3-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age is not inferior at the predefined margin to that achieved with ROTARIX® , when administered orally as 2-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of ageTimepoint: Day 0 ,84 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety solicited for 7 days, unsolicited, SAEs throughout the study periodTimepoint: 84 days | — |
Countries
India
Contacts
Public ContactDr Binod Sah
Bharat biotech International Limited
Outcome results
None listed