Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants

Inclusion Criteria: * Healthy infants 6-8 weeks of age of either sex; * Born after a gestational period of 36-42 weeks with birth weight \>2 kg; * Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF); * Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up. Exclusion Criteria: * History of congenital abdominal disorders, intussusception, or abdominal surgery; * Known or suspected impairment of immunological function; * Known hypersensitivity to any component of the rotavirus vaccine; * Prior receipt of any rotavirus vaccine; * Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff? * History of known rotavirus disease, chronic diarrhea, or failure to thrive; * Baseline level of ALT or AST \>2.5 times the upper limit of normal; * Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication); * Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study); * Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids); * Infants testing positive for HBV, HCV, or HIV infection; * Prior receipt of a blood transfusion or blood products, including immunoglobulins; * Any infants who can not be adequately followed for safety by telephone and/or a home visit; * Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.