CTRI/2019/03/017934
Completed
Phase 4
Phase IV, Randomized, Multi Centre, Open label Study to Evaluate Lot to Lot consistency of Liquid ROTAVAC 5CM (Live Attenuated Rotavirus Vaccine) as a 3-Dose Series. - ROTAVAC 5CM
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited
- Enrollment
- 384
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy infants as established by medical history and clinical examination before entering the study.
- •2\.Age: 6\-8 weeks
- •3\.Weight: \>\=2\.5 kgs at birth
- •4\.Infants received age\-appropriate UIP vaccines till enrolment and during the study.
- •5\.Parental ability and willingness to provide informed consent.
- •6\.Parent who intends to remain in the area with the subject during the study period.
Exclusion Criteria
- •Any of the following criteria will preclude the participant from being enrolled in the study:
- •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\.Concurrent participation in another clinical trial.
- •4\.Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the childâ??s health or is likely to result in non\-conformance to the protocol.
- •5\.History of congenital abdominal disorders, intussusception, abdominal surgery.
- •6\.Household contact with an immunosuppressed individual or pregnant woman.
- •7\.Prior receipt of rotavirus vaccine.
- •8\.A known sensitivity or allergy to any components of the study vaccines.
- •9\.Major congenital or genetic defect.
Outcomes
Primary Outcomes
Not specified
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