Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.

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 written informed consent.
• Parent who intends to remain in the area with the child during the study period.
• Receipt of birth dose of Hepatitis B vaccine and OPV.

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 at any point throughout the entire timeframe for this study.
• Presence of significant malnutrition or any systemic disorder 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 or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
• A known sensitivity or allergy to any components of the study vaccine.
• Clinically detectable congenital or genetic defect.
• History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
• Receipt of 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 written informed consent.