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

This is an interventional prevention trial for Rotavirus Gastroenteritis focused on measuring rotavirus, rotavirus vaccine, BRV-PV Read More

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 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.