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1 Clinical Trial Details (PDF Generation Date :- Sun, 14 Apr :03:43 GMT) CTRI Number Last Modified On 30/10/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/05/ [Registered on: 23/05/2013] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group, Placebo Controlled Trial A clinical trial to study the effect and safety of Rotavirus Vaccine against Severe Rotavirus Gastroenteritis in healthy n Infants Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) against Severe Rotavirus Gastroenteritis in Healthy n Infants Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) ROTA:03/12 Version 4.1 Dated 30 July 2013 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details Contact Person (Scientific Query) Dr Prasad Kulkarni Medical Director. 212/2, Off Soli Poonawala Road, Hadapsar, drpsk@seruminstitute.com Details Contact Person (Public Query) Dr Sajjad Desai Deputy Medical Director. 212/2, Off Soli Poonawala Road, Hadapsar, page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > PATH Vaccine Solutions Source of Monetary or Material Support >., PATH Vaccine Solutions Type of Sponsor NIL List of Countries of Principal Investigator Dr Nidhi Goyal Dr B S Garg Dr Dinesh Kumar Dr Veena G Kamath Dr Suman Kanungo Primary Sponsor Details. 212/2, Off Soli Poonawala Road,Hadapsar, Pharmaceutical industry-n NIL of Site Site // Center for Health Research and Development (CHRD) - Society for Applied Studies (SAS) Dr. Sushila Nayar School of Public Health, Sewagram, Maharashtra Government Medical College, Jammu Kasturba Medical College, Manipal National Institute of Cholera & Enteric Diseases Center for Health Research and Development (CHRD), Society for Applied Studies (SAS), 680, Gali No. 5, Nai Basti, Devli Gaon, New Delhi New Delhi DELHI Dr. Sushila Nayar School of Public Health Mahatma Gandhi Institute of Medical Sciences, Department of Community Medicines, Sewagram, Maharashtra. Department of Community Medicine, Government Medical College, Bakshi Nagar, Jammu Jammu JAMMU & KASHMIR Department of Community Medicine, Kasturba Medical College, Manipal, Karnataka, PIN Udupi KARNATAKA Division of Epidemiology, National Institute of Cholera & Enteric Diseases,P 33 CIT Road, Scheme XM, nidhi.goyal@sas.org.in gargbs@gmail.com dineshgmcjamcmcl@g mail.com veenak@manipal.edu sumankanungo@gmail. com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr Anand Kawade Vadu Rural Health Program, Shirdi Sai Baba Rural Hospital, Division of KEM Hospital, Beliaghata, Kolkata Kolkata WEST BENGAL Vadu Rural Health Program, Shirdi Sai Baba Rural Hospital A division of KEM Hospital,, Village-Vadu(Budruk), Tal-Shirur, askawade@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Human Ethics Committee of Translational Health Science and Technology Institute (THSTI), Gurgaon Approved 04/07/2014 No Committee Government Medical College, Jammu Approved 30/01/2014 No Committee National Institute of Cholera & Enteric Diseases, Kolkata Committee, KEM Hospital and Research Center, Mahatma Gandhi Institute of Medical Sciences Institutional Ethics Committee Manipal University Ethics Committee, Manipal Status Approved 17/10/2013 No Approved 30/09/2013 No Approved 03/10/2013 No Approved 14/09/2013 No Date Approved/Obtained 01/04/2014 Health Type Healthy Human Volunteers Condition Gastroenteritis caused by Rotavirus in n infants Type Details Intervention Rotavirus Vaccine Three doses of BRV-PV will be administered concomitantly with UIP vaccines at 4 weeks intervals between doses (with a window of 1 to +4 weeks). The first administration will occur at 6-8 weeks of age. Comparator Agent Placebo Three doses of placebo will be page 3 / 5

4 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age From Age To Gender Details Details Day(s) Day(s) Both Computer generated randomization Centralized Double Blind Double Dummy Inclusion Criteria administered concomitantly with UIP vaccines at 4 weeks intervals between doses (with a window of 1 to +4 weeks). The first administration will occur at 6-8 weeks of age. 1. Healthy infants as established by medical history and clinical examination before entering the study. 2. Age: 6-8 weeks 3. Parent/legal guardian ability and willingness to provide informed consent. 4. Parent/legal guardian who intends to remain in the area with the child during the study period. Exclusion Criteria 1. Acute disease at the time of enrollment (temporary exclusion) 2. Concurrent participation in another clinical trial throughout the entire timeframe of this study. 3. History of congenital abdominal disorders, intussusception, abdominal surgery 4. Prior receipt of rotavirus vaccine. 5. Major congenital or genetic defect. 6. Participant s parents not able, available or willing to accept active weekly follow-up by the study staff. Primary Outcome Outcome Timepoints Cases of severe rotavirus gastroenteritis 14th day after the third dose of vaccine occurring in infants receiving the complete administration vaccination regimen occurring from 14 days after the third vaccine dose until all participating infants reach two years of age. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Safety: 1.Solicited post-vaccination reactions Efficacy:1. Laboratory-confirmed cases of severe rotavirus gastroenteritis due to rotavirus 2. Vaccine impact on the number of severe rotavirus gastroenteritis cases per 100 children/year Total Sample Size=7500 Sample Size from = /05/2014 No Date Specified Years=3 for 2 Years page 4 / 5

5 Powered by TCPDF ( Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Months=6 Days=0 Not Applicable Completed This study is a phase III, multicenter, randomized, double-blind, placebo-controlled study which will evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) against Severe Rotavirus Gastroenteritis in healthy n infants. Total 7500 n infants will be receiving either BRV-PV vaccine or placebo at 1:1 ratio. Eligible study participants in respective randomization groups will be administered with three doses of vaccine/placebo orally with the first administration at 6-8 weeks of life. page 5 / 5