CTRI/2016/11/007481
Completed
Phase 3
A phase III, multicenter, randomized, open labeled study to evaluate the immunogenicity, reactogenicity and safety of ROTAVAC 5CM of the live attenuated rotavirus vaccine as a 3 dose series when compared with existing ROTAVAC® in healthy infants aged 6-8 weeks - ROTAVAC5CM
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bharat Biotech International Limited
- Enrollment
- 360
- 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 and \>\=4 kgs at the time of enrollment/randomization
- •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
- •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\.Prior receipt of rotavirus vaccine.
- •7\.A known sensitivity or allergy to any components of the study vaccines.
- •8\.Major congenital or genetic defect.
- •9\.History of persistent diarrhea (defined as diarrhea of more than 14 days).
- •10\.Subjectâ??s parents not able, available or willing to accept active follow\-up by the study staff.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
A phase III study of LDK378 versus standard chemotherapy in ALK+ advanced NSCLC patients who have been previously treated with chemotherapy and crizotinibon small cell lung cancerJPRN-jRCT2080222222ovartis Pharma. K.K.231
Active, not recruiting
Phase 1
A study to compare oral asciminib versus existing TKI medicines in patients with newly diagnosed CMEUCTR2021-000678-27-FRovartis Pharma AG402
Recruiting
Phase 3
A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic PhaseNL-OMON51998ovartis2
Active, not recruiting
Phase 3
A study of oral asciminib versus other TKIs in adult patients with newly diagnosed Ph+ CML-CPJPRN-jRCT2021210060Kazuyuki Suzuki36
Active, not recruiting
Phase 1
A study to compare oral asciminib versus existing TKI medicines in patients with newly diagnosed CMEUCTR2021-000678-27-ITOVARTIS PHARMA AG402