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1 Clinical Trial Details (PDF Generation Date :- Tue, 17 Jul :11:24 GMT) CTRI Number Last Modified On 10/06/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/12/ [Registered on: 08/12/2015] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group, Active Controlled Trial Randomized open label study to compare immunogenicity and safety of ROTAVAC and ROTARIX rotavirus vaccine. A randomized open label multi-center study to compare immunogenicity and safety of BBIL s ROTAVAC to GSK s ROTARIX rotavirus vaccine when administered orally to infants aged 6-8 weeks. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) BBIL/ROTA/IV-2/2015 Version 1.0 dated 20/07/2015 Protocol Number Details of Principal Investigator Genome Valley Shameerpet Details Contact Person (Scientific Query) Genome Valley Shameerpet Details Contact Person (Public Query) Genome Valley Shameerpet page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee > Type of Sponsor NIL List of Countries of Principal Investigator Dr Savitha MR Source of Monetary or Material Support Primary Sponsor Details Genome valley,shameerpet, Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Cheluvamba Hospital. Mysore Pediatrics, Cheluvamba Hospiatl Mysore KARNATAKA Dr Ram Ganeshan King George Hospital Pediatrics, Ist Floor, Maharani peta Visakhapatnam Dr N S Mahantshetti Dr Vimal kant goyal Dr Ashish Ramchandra Dhongade KLES Dr Prabhakar Kore Hospital and MRC Panchsheel Hospitals Pvt. LTD Sant Dnyaneshwar Medical Education Research Centre OPD No:8&9, pediatrics KLES Dr Prabhakar Kore Hospital and MRC Belgaum KARNATAKA C-3/63A,64-A,Yamuna vihar,(opp.gokal Puri police station),delhi New Delhi DELHI Paediatrics,Sant Dnyaneshwar Medical Education Research Centre 695-A,Sadashiv Peth,Laxmi Road, Opp.Vijay Talkies, Pune Pune MAHARASHTRA drsavithamr@gmail.co m fbnc.amc@gmail.com niranjanasn@yahoo.co m panchsheelhospital@g mail.com ramdhongade@hotmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee KLE University Ethics Committee, Panchsheel Hospital Approved 14/12/2015 No Approved 14/12/2015 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Institutional Ethics Committee King George Hospital Institutional Ethics committee Mysore Medical College &Research Institute& Associated Hospitals Sant Dnyaneshwar Medical Education Research Center Institutional Review Board Status Approved 03/12/2015 No Approved 22/12/2015 No Approved 29/12/2015 No Date Approved/Obtained 01/12/2015 Health Type Healthy Human Volunteers Condition Healthy subjects Type Details Intervention ROTAVAC 0.5mL single dose containing NLT 105.0ffu of live rotavirus 116E. ROTAVAC is administered as three doses at4 (+1) weeks interval starting at 6-8 weeks of age. The vaccine is administered orally via the dropper provided with the vial. ROTAVAC should be fully thawed (till liquid) before administration Comparator Agent ROTARIX Each 1-mL dose contains a suspension of at least median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P[8] rotavirus after reconstitution. Vial of lyophilized vaccine to be reconstituted with liquid diluents in a prefilled oral applicator. The vaccine is administered orally. ROTARIX is administered as two doses starting at 6-8 weeks of age and the second dose at 4 (+1) week interval. Age From Age To Gender Details Day(s) Day(s) Both 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 page 3 / 5

4 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization An Open list of random numbers Open Label 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 child?s health or is likely to result in non-conformance to the protocol. 5. History of congenital abdominal disorders, intussusception, abdominal surgery 6. Known or suspected impairment of immunological function based on medical history and physical examination. 7. Household contact with an immunosuppressed individual or pregnant woman. 8. Prior receipt of rotavirus vaccine. 9. A known sensitivity or allergy to any components of the study vaccines. 10. Major congenital or genetic defect. 11. History of persistent diarrhea (defined as diarrhea more than 14 days). 12. Subject?s parents not able, available or willing to accept active follow-up by the study staff. 13. Has received any immunoglobulin therapy and/or blood products since birth. 14. History of chronic administration (defined as more than 14 days) of immunosuppressant?s including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 15. History of any neurologic disorders or seizures. 16. 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 subject?s parent?s/legally acceptable representative?s ability to give informed consent Primary Outcome Outcome Timepoints The difference in immunogenicity (GMTs) Day 0,84 achieved with ROTAVAC, when administered orally as 3-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age is not inferior at the predefined margin to that achieved with ROTARIX, when administered orally as 2-dose regimen at 4(+1) weeks interval starting at 6-8 weeks of age Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 safety solicited for 7 days, unsolicited, SAEs throughout the study period Total Sample Size=464 Sample Size from = days page 4 / 5

5 Powered by TCPDF ( PDF of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 14/12/2015 No Date Specified Years=0 Months=6 Days=0 Not Applicable Completed The study is designed as an open-labeled active comparator clinical study to demonstrate non-inferiority of ROTAVAC when compared to ROTARIX with respect to sero response measured as geometric mean titres (GMTs) of serum anti rotavirus IgA at pre-vaccination and post-vaccination time points Assessment for immediate adverse event occurring in 30 minutes after vaccine administration, solicited adverse events over the 7-day period after each vaccination will be conducted all the subjects. The eligible, subjects will be enrolled into the study and will receive vaccine as per randomization. Subjects shall be observed for 30 minutes after vaccination. The parents/care giver of the subject will be provided with subject diary cards and instructed to record and report any symptoms during the next 7 days. The diary card will be collected and reviewed at the next study visit. Additionally, study staff will contact the parents/caregivers of the subject every other day during this period to review any symptoms of adverse events. All solicited AEs will be recorded in the CRF. Following administration of the vaccine, safety will be measured by assessment of adverse events (solicited and unsolicited) during the entire period of study participation i.e., 4-6 weeks after 3rd dose. Further, serious adverse events will be monitored for all subjects during the study page 5 / 5