A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants

Inclusion Criteria: * Healthy infants as established by medical history and clinical examination before entering the study. * Age: 6-8 weeks at the time of enrollment. * Parental ability and willingness to provide informed consent. * Parent who intends to remain in the area with the child during the study period. Exclusion Criteria: * Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion) * Presence of fever on the day of enrollment (temporary exclusion). * Acute disease at the time of enrollment (temporary exclusion) * Concurrent participation in another clinical trial throughout the entire timeframe for this study. * Presence of significant malnutrition (weight-for-height z-score \<-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery * Known or suspected impairment of immunological function based on medical history and physical examination. * Household contact with an immunosuppressed individual or pregnant woman. * Prior receipt of rotavirus vaccine. * A known sensitivity or allergy to any components of the study vaccine. * Major cong…