Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

Exclusion Criteria

• •Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
• •Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).
• •Concurrent participation in another clinical trial.
• •Presence of significant malnutrition 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 infant's health or is likely to result in non-conformance to the protocol.
• •History of congenital abdominal disorders, intussusception, abdominal surgery
• •Known or suspected impairment of immunological function based on medical history and physical examination.
• •Prior receipt of rotavirus vaccine.
• •A known sensitivity or allergy to any components of the study medication.
• •Major congenital or genetic defect.
• •Participant's parents not able, available or willing to accept active 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/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.