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

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.