Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

Inclusion Criteria:

1. Healthy infant as established by medical history and clinical examination beforeentering the study.
2. Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
3. Infants received age-appropriate EPI vaccines till enrolment.
4. Ability and willingness to provide informed consent as per local consentingprocedures.
5. Parent can be contacted on phone and confirms intention to remain in the study areawith the participant during the study period.

Exclusion Criteria:

1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
2. Presence of fever on the day of enrolment (temporary exclusion).
3. Acute disease at the time of enrolment (temporary exclusion).
4. Concurrent participation in another clinical trial throughout the entire timeframe ofthis study.
5. Presence of severe malnutrition (weight-for-height z-score < -3SD median).
6. Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal,hematological, endocrine, immunological, dermatological, neurological, cancer orautoimmune disease) as determined by medical history and/or physical examination whichwould compromise the child's health or is likely to result in non-conformance to theprotocol.
7. History of congenital abdominal disorders, intussusception, abdominal surgery
8. Known or suspected impairment of immunological function based on medical history andphysical examination.
9. Prior receipt or intent to receive rotavirus and other age specified EPI vaccinesoutside of the study center and during study participation.
10. A known sensitivity or allergy to any component of the study vaccine.
11. Clinically detectable significant congenital or genetic defect.
12. History of persistent diarrhea (defined as diarrhea more than 14 days).
13. Participant's parents not able, available or willing to accept active follow-up by thestudy staff.
14. Has received any immunoglobulin therapy and/or blood products since birth or plannedadministration during the study period.
15. History of chronic administration (defined as more than 14 days) of immunosuppressantsincluding corticosteroids. Infants on inhaled or topical steroids may be permitted toparticipate in the study.
16. History of any neurologic disorders or seizures.
17. Any medical condition in the parents/infants that, in the judgment of theinvestigator, would interfere with or serves as a contraindication to protocoladherence or a participant's parent's/legally acceptable representative's ability togive informed consent.
18. Participant is a direct descendant (child or grandchild) of any person employed by theSponsor, the CRO, the PI or study site personnel.