REF/2015/02/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Sun, 13 May :38:30 GMT) CTRI Nuber Last Modified On 25/05/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/02/ [Registered on: 25/02/2015] - Trial Registered Prospectively No Interventional Vaccine Randoized, Parallel Group, Multiple Ar Trial A clinical study to deterine the safety and efficacy of a new liquid vaccine (ROTAVAC 5C) against childhood diarrhea that is caused by rotavirus A sealess, sequential Phase III, randoized, ulti center single-blind study to evaluate iunogenicity, safety, reactogenicity of liquid ROTAVAC 5C forulation of the live attenuated rotavirus vaccine as a 3-dose series when copared with ROTAVAC in infants Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) BBIL/ROTA 5C/III/2014; Version: 1.2; Dated: 19/9/2015 Designation Affiliation Protocol Nuber Details of Principal Investigator Dr Krishna Mohan Executive Drector Phone Fax Eail Designation Affiliation Bharat Biotech International Ltd Genoe Valley, Shaeerpet, Hyderabad Hyderabad ANDHRA PRADESH kohan@bharatbiotech.co Details Contact Person (Scientific Query) Dr Krishna Mohan Executive Drector Phone Fax Eail Designation Affiliation Bharat Biotech International Ltd Genoe Valley, Shaeerpet, Hyderabad Hyderabad ANDHRA PRADESH kohan@bharatbiotech.co Details Contact Person (Public Query) Dr Krishna Mohan Executive Drector Phone Bharat Biotech International Ltd Genoe Valley, Shaeerpet, Hyderabad Hyderabad ANDHRA PRADESH page 1 / 8

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Fax Eail Source of Monetary or Material Support > Bharat Biotech International Ltd Genoe Valley, Shaeerpet, Hyderabad TELANGANA Type of Sponsor NIL List of Countries Viet Na of Principal Investigator Dr Ashok Kuar Dr Jayant Vagha Dr Ua Nayak Dr Monjori Mitra Dr D Narayanappa Dr Sonali Kar Priary Sponsor Details Bharat Biotech International Ltd Genoe Valley, Shaeerpet, Hyderabad , Andhra Pradesh, Pharaceutical industry-n NIL of Site Site Phone/Fax/Eail Banaras Hindu University,Varanasi Datta Megha Institute of edical Sciences, Acharya Vinoba Bhave Rural Hospital, Warda GMERS Medical College &GH, Gotri,Vadodara Institute of Child Health, Kolkata Jagadguru Shivarathreeshwara Medical College, Mysore Kalinga Institute of Medical Sciences, Odisha Pediatrics, Institute of Medical Science, Banaras Hindu University Varanasi UTTAR PRADESH Pediatrics, Datta Megha Institute of edical Sciences, Acharya Vinoba Bhave Rural Hospital,Sawangi Wardha MAHARASHTRA Pediatrics, GMERS Medical College &GH, Gotri,Baroda Vadodara GUJARAT Roo No:111, Departant: OPD Pediatric Division, 11 Dr.Biresh Guha Street Kolkata WEST BENGAL Pediatrics, JSS edical College and Hospital Mahata Gandhi road Mysore KARNATAKA Roo No:42 Departent: Iunization Clinic, Division: ashokkuar_bhu@hot ail.co jayantvagha@gail.co uanayak@gail.co onjorir@gail.co sinchabhi@yahoo.co.uk sonsa72@yahoo.co.u k page 2 / 8

3 Dr Vasant M Khalatkar Khalatkar Hospital, Nagpur Counity Medicine KIMS, Patia,BBSR-24 Khordha ORISSA R-29,Reshibagh,Ur er Road Nagpur MAHARASHTRA Dr A Sway Naidu King George Hospital Pediatrics, Ist Floor, King George Hospital Visakhapatna ANDHRA PRADESH Dr N S Mahantshetti Dr Pawan Shara Dr Sangeeta Yadav Dr A Kannan Dr Ashish Raachandra Dhongade Dr P K Purthi Dr Satyajit Mahapatra KLES Dr Prabhakar Kore Hospital and MRC Maharshi Child Hospital, Jaipur Maulana Azad Medical College, New Delhi Meenakshi Mission Hospital,Madurai Sant Dnyaneshwar Medical Education Research Centern Sir Ganga Ra Hospital, Delhi SRM Medical College Hospital & Research Centre, Chennai OPD No:8&9, pediatrics KLES Dr Prabhakar Kore Hospital and MRC Belgau KARNATAKA Pediatrics Maharshi Child hospital A-45 Subash nagar Shopping Center, TB sanatoriu Road Jaipur RAJASTHAN Pediatrics Maulana azad Medical College New Delhi DELHI Pediatrics Meenakshi Mission Hospital, lake area,melur Road Madurai TAMIL NADU Sant Dnyaneshwar Medical Education Research Center, 695 -A, Sadashiv Peth, Laxi Road, Opp. Vijay Talkies, Pune Pune MAHARASHTRA R-503, Pediatrics Sir, Gangara Hospital Marg, Rajinder Nagar New Delhi DELHI Pediatrics SRM University, Potheri, Kattankulathur Chennai TAMIL NADU vasant.khalatkar@gail.co fbnc.ac@gail.co niranjanasn@yahoo.co drpshara2007@rediff ail.co sangeetayadava@gai l.co kh.khannan@gail.co adhongade1@gail.co pkpruthi@hotail.co satyajit_p@yahoo.co page 3 / 8

4 Details of Ethics Coittee Regulatory Clearance Status fro DCGI Health Condition / Probles Studied of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? Ethics Coittee Sir Ganga Ra Hospital Ethics coittee, Institute of edical Science, Varnasi Institute of Child Health, Kolkata coittee, dattaeghe institute of edical sciences, Wardha coittee, GMERS Medical Collage, Gujarat Coittee, JSS Medical Collage, Mysore coittee, King George Hospital, Vishakapatna Coittee, SRM MCH & RC, Tail nadu Coittee,Maulana Azad Medical College, New Delhi Coittee,Meenakshi Mission Hospital and Research Centre, Tailnadu Jasleen hospitals Ethics coittee, Nagpur Kalinga Institute of Medical Sciences, Orissa KLE university, Belgau Sant Dnyaneshwar Medical Education research center Institutional Review Board Seroc ethics coittee,jaipur Status Approved 18/01/2016 No Approved 31/03/2015 No Approved 04/04/2015 No Approved 20/04/2015 No Approved 21/07/2015 No Approved 03/03/2015 No Approved 28/02/2015 No Approved 30/03/2015 No Approved 03/03/2015 No Approved 29/12/2015 No Approved 07/03/2015 No Approved 13/07/2015 No Approved 19/03/2015 No Approved 14/10/2016 No Approved 08/09/2015 No Date Approved/Obtained 29/01/2015 Health Type Healthy Huan Volunteers Condition Rotavirus Gastroenteritis page 4 / 8

5 Intervention / Coparator Agent Inclusion Criteria Type Details Intervention Intervention ROTAVAC 5C forulation BBIL-R ROTAVAC 5C forulation BBIL-R Single dose adinistered orally as three doses at 4 (+1) weeks interval. Single dose adinistered orally as three doses at 4 (+1) weeks interval. Coparator Agent ROTAVAC Single dose adinistered orally as three doses at 4 (+1) weeks interval; antacid buffer (2.5L/dose sodiu bicarbonate citrate) to be adinistered 5 in prior to the vaccine. Age Fro Age To Gender Details Day(s) Day(s) Both Inclusion Criteria 1.Healthy infants as established by edical history and clinical exaination before entering the study. 2.Age: 6-8 weeks 3.Weight?2.5 kgs at birth. 4.Infants received EPI vaccines (OPV, BCG and Hep B) at birth. 5.Parental ability and willingness to provide infored consent. 6.Parent who intends to reain in the area with the participant during the study period. Exclusion Criteria Details Exclusion Criteria 1.Presence of diarrhoea or voiting in the previous 72 hours or on the day of enrolent (teporary exclusion). 2.Presence of fever on the day of enrolent (teporary exclusion). 3.Concurrent participation in another clinical trial. 4.Presence of significant alnutrition or any systeic disorder (cardiovascular, pulonary, hepatic, renal, gastrointestinal, haeatological, endocrine, iuno-logical, deratological, neurological, cancer or autoiune disease) as deterined by edical history and/or physical exaination which would coproise the child s health or is likely to result in non-conforance to the protocol. 5.History of congenital abdoinal disorders, intussusception, abdoinal surgery 6.Known or suspected ipairent of iunological function based on edical history and physical exaination. 7.Household contact with an iunosuppressed individual or pregnant woan. 8.Prior receipt of rotavirus vaccine. 9.A known sensitivity or allergy to any coponents of the study vaccines. 10.Major congenital or genetic defect. 11.History of persistent diarrhoea (defined as diarrhoea ore than 14 days). 12.Participant s parents not able, available or willing to accept active follow-up by the study staff. 13.Has received any iunoglobulin therapy and/or blood products since birth. 14.History of chronic adinistration (defined as ore than 14 days) of iunosuppressants including corticosteroids. Infants on inhaled or topical steroids ay be peritted to participate in the study. page 5 / 8

6 15.History of any neurologic disorders or seizures. 16.Any edical condition in the parents/infants that, in the judgent of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant s parent s/legally acceptable representative s ability to give infored consent. Method of Generating Rando Sequence Method of Concealent Blinding/Masking Coputer generated randoization An Open list of rando nubers Outcoe Assessor Blinded Priary Outcoe Outcoe Tiepoints Exploratory Phase The difference in iunogenicity achieved with two forulations of ROTAVAC 5C will not be statistically significant to that achieved with ROTAVAC, when adinistered orally as 3-dose regien. Safety assessent of ROTAVAC 5C forulations. Confiratory Phase Establish lot consistency and iunogenicity in each treatent ar at 4-6 weeks after adinistration of 3rd dose in coparison to baseline levels. Exploratory Phase Baseline and 4-6 weeks post 3rd dose. Confiratory Phase Baseline, 4-5 weeks post 2nd dose and 4-6 weeks post 3rd dose. Secondary Outcoe Outcoe Tiepoints Exploratory phase: Evaluation of shedding of Stool specien: Day 3 and 7 after each vaccine rotavirus. dose Confiratory Phase: Assess 4- fold rise in seru Iunogenicity and Sero-response to childhood anti-rotavirus IgA titers 4-6 weeks after vaccines: : Baseline and 4-6 weeks after 3rd adinistration of 3rd dose in coparison to dose baseline titers in all groups. Safety: Throughout the study period Assess sero response to childhood vaccines Asses vaccine reactogenicity and safety of the two forulations of ROTAVAC 5C and ROTAVAC. Target Saple Size Phase of Trial Phase 3 Date of First Enrollent () Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial () Publication Details Brief Suary Total Saple Size=1975 Saple Size fro = /03/ /10/2015 Years=2 Months=0 Days=0 Not Applicable Copleted Study Rationale page 6 / 8

7 A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, adinistrative and distribution ease, especially in routine iunization progra. The advantages of the liquid vaccines are: Liquid vaccines take lesser tie to adinister copared to the current practice of giving antacid buffer prior to vaccine which takes 40% ore tie to adinister. Easier to transport as it is stable at C copared to the frozen forulation that needs to be stored at C and transported in dry ice. Chances of huan error during adinistration are lesser than the sequential adinistration of antacid and vaccine. Study Design and plan The study is designed as an adaptive, sealess sequential ulticenter, single-blinded, randoized clinical trial with two phases: exploratory phase and confiratory phase. Exploratory phase: 1. Infants of 6-8 weeks of age will randoly be assigned to receive 3 doses of two different forulations of ROTAVAC 5C (BBIL-R &BBILR2014-2) or ROTAVAC. In this phase, iunogenicity and safety of the two new forulations will be copared with each other and with ROTAVAC in the three treatent ars when adinistered at 4 weeks interval (+1week window). The first dose will be adinistered at 6-8 weeks of age. Each of the rotavirus vaccine forulations contains NLT 10 5 fluorescent focus units (FFU)/Dose. After copletion of the exploratory phase, analyses will be undertaken for selection of the ost suitable forulation to undergo confiratory phase of the study. Confiratory Phase: 1. Infants of 6-8 weeks of age will randoly be assigned to receive 3 doses of the selected forulation of ROTAVAC 5C (3 production lots) and ROTAVAC to evaluate lot consistency. Additionally, non-interference with iune response to antigens contained in childhood vaccines will be evaluated. page 7 / 8

8 Powered by TCPDF ( REF/2015/02/ Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain inforation on solicited adverse events.( Reactogenicity ) 3. Surveillance for unsolicited AEs for all participants will be conducted fro the tie between first dose and 4-6 weeks after the 3rd dose. Surveillance for SAEs for all participants will be conducted fro the tie between first dose and 4-6 weeks after the 3rd dose. page 8 / 8