Clinical trial on Liquid Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to compare vaccine non-inferiority with ROTASIIL vaccine in healthy children in India
Phase 2
Completed
- Registration Number
- CTRI/2017/10/010104
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
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
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.Presence of acute disease at the time of enrollment (temporary exclusion).
4.Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To demonstrate non-inferiority in the immunogenicity of LBRV-PV as compared with ROTASIIL (lyophilized BRV-PV) in infants.Timepoint: 28 days post dose 3
- Secondary Outcome Measures
Name Time Method â?¢To evaluate the safety of LBRV-PV in terms of immediate post-vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.Timepoint: Throughout the study period