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.