A clinical trial to study the effect and safety of Rotavirus Vaccine against Severe Rotavirus Gastroenteritis in healthy Indian Infants

Phase 3

Completed

Recruitment & Eligibility

Inclusion Criteria

1.Healthy infants as established by medical history and clinical examination before entering the study.

2.Age: 6-8 weeks

3.Parent/legal guardian ability and willingness to provide informed consent.

4.Parent/legal guardian who intends to remain in the area with the child during the study period.

Exclusion Criteria

1.Acute disease at the time of enrollment (temporary exclusion)

2.Concurrent participation in another clinical trial throughout the entire timeframe of this study.

3.History of congenital abdominal disorders, intussusception, abdominal surgery

4.Prior receipt of rotavirus vaccine.

5.Major congenital or genetic defect.

6.Participantâ??s parents not able, available or willing to accept active weekly follow-up by the study staff.

Primary Outcome Measures

Name	Time	Method
Cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until all participating infants reach two years of age.Timepoint: 14th day after the third dose of vaccine administration

Secondary Outcome Measures

Name	Time	Method
Safety: <br/ ><br>1.Solicited post-vaccination reactions <br/ ><br> <br/ ><br>Efficacy:1.Laboratory-confirmed cases of severe rotavirus gastroenteritis due to rotavirus <br/ ><br>2.Vaccine impact on the number of severe rotavirus gastroenteritis cases per 100 children/yearTimepoint: for 2 Years