Phase III Study of Liquid Formulation of ROTAVIN

This is an interventional prevention trial for Diarrhea focused on measuring ROTAVIN, Rotavirus vaccine, Rotavirus, Diarrhea Read More

Inclusion Criteria:

1. Healthy infants as established by medical history and clinical examination before entering the study.
2. Age: 60-91 days (both days inclusive) at the time of enrollment.
3. Parental/legally acceptable representative ability and willingness to provide written informed consent.
4. Parent/legally acceptable representative who intends to remain in the area with the child during the study period.

Exclusion Criteria:

1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
2. Presence of fever on the day of enrollment (temporary exclusion).
3. Acute disease at the time of enrollment (temporary exclusion).
4. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study.
5. Presence of significant malnutrition (weight-for-height z-score < -3 SD median)
6. Presence of 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 participant's health or is likely to result in nonconformance to the protocol.
7. History of congenital abdominal disorders, intussusception, or abdominal surgery.
8. Known or suspected impairment of immunological function based on medical history and physical examination.
9. Household contact with an immunosuppressed individual or pregnant woman.
10. Prior receipt of rotavirus or an intent to receive this vaccine from outside of the study center during study participation.
11. Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 days or plan to receive them within next 7 days.
12. A known sensitivity or allergy to any components of the study vaccine.
13. History of allergy to antibiotic kanamycin.
14. Clinically detectable significant congenital or genetic defect.
15. History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
16. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period.
17. 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.
18. Any medical condition in the parent/legally acceptable representative or infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.