None listed
Conditions
Interventions
Intervention1: Rotavac 5CM: 0.5 ml of Rotavac 5CM will be administered orally at 6 to 8 weeks of age
Control Intervention1: ROTAVAC®: 0.5 ml of ROTAVAC® will be administered orally at 6 to 8 weeks o
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 and >=4 kgs at the time of enrollment/randomization 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. Prior receipt of rotavirus vaccine. 7. A known sensitivity or allergy to any components of the study vaccines. 8. Major congenital or genetic defect. 9. History of persistent diarrhea (defined as diarrhea of more than 14 days). 10. Subjectâ??s parents not able, available or willing to accept active follow-up by the study staff. 11. Has received any immunoglobulin therapy and/or blood products since birth. 12. 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, at the discretion of the principal investigator. 13. History of any neurologic disorders or seizures. 14. 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. 15. Asubjectâ??s parentâ??s/legally acceptable representativeâ??s inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The immunogenicity (GMTs) achieved with ROTAVAC 5CM, when administered orally as 3-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age to that achieved with ROTAVAC®, starting at 6-8 weeks of age.Timepoint: 0 and 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Immunogenicity rates of ROTAVAC 5CM and ROTAVAC® as determined by 4 - fold rise in serum anti-rotavirus IgA titers 4-5 weeks after administration of 3rd dose in comparison to baseline titers 2.To assess adverse events 30 minutes and 7 days post vaccination 3.To assess unsolicited & solicited adverse events and serious adverse events during the study periodTimepoint: 0 and 84 | — |
Countries
India
Contacts
Public ContactDr V Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed