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

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 congenital or genetic defect.
• •History of persistent diarrhea (defined as diarrhea more than 14 days).
• •Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
• •Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
• •History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
• •History of any neurologic disorders or seizures.
• •Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.