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1 Clinical Trial Details (PDF Generation Date :- Mon, 25 Mar :33:33 GMT) CTRI Number Last Modified On 14/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2014/04/ [Registered on: 17/04/2014] - Trial Registered Prospectively No Interventional Vaccine Randomized, Parallel Group, Multiple Arm Trial A Phase IV Immunogenicity and Safety Study of BBIL s Oral Rotavirus Vaccine 116E (ROTAVAC) Phase IV, multicenter, randomized, single-blind, study to evaluate the immunogenicity, reactogenicity & safety of the live attenuated rotavirus vaccine ROTAVAC as a 3 dose series when administered simultaneously with or without the buffering agent following in healthy infants 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/2013; Version1.0; Dated 12/09/2013 Designation Affiliation Protocol Number Details of Principal Investigator Dr B N Patnaik Associate Director Phone Fax Designation Affiliation Genome Valley, Shameerpet, Hyderabad ANDHRA PRADESH badri2299@bharatbiotech.com Details Contact Person (Scientific Query) Dr B N Patnaik Associate Director Phone Fax Designation Affiliation Genome Valley, Shameerpet, Hyderabad ANDHRA PRADESH badri2299@bharatbiotech.com Details Contact Person (Public Query) Dr B N Patnaik Associate Director Phone Fax Genome Valley, Shameerpet, Hyderabad ANDHRA PRADESH page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > Type of Sponsor NIL List of Countries of Principal Investigator Dr Vijay P Warad Dr Monjori Mitra Dr D Narayanappa Dr Sonali Kar Dr Nimain C Mohanty Dr B J Mahendra DR V K Goyal badri2299@bharatbiotech.com Source of Monetary or Material Support Primary Sponsor Details Genome Valley, Shameerpet, Hyderabad , Andhra Pradesh, Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Inmadar Multspeciality Hospital, Pune Institute of Child Health, Kolkata Jagadguru Sri shivarathreeshwara medical collage & hospital, Mysore Kalinga Institute of Medical Sciences, Orissa Mahatma Gandhi Mission Hospital, Navi Mumbai Mandya Institute of Medical Sciences, Mandya Panchsheel Hospital Pvt. Ltd Hospital Building,S.No.15 Fatimanagar Pune MAHARASHTRA vijaypwarad@gmail.co m Room No: Department: OPD Pediatric Division monjorimr@gmail.com Institute of Child Health, 11Dr.Biresh Guha Street Kolkata WEST BENGAL Pediatrics JSS medical collage and Hospital Mahathma Gandi road Mysore KARNATAKA Room No: 42 Departme nt:immunization Clinic, KIMS Hospital Divison: Community Medicine, KIMS, Patia, BBSR-24 Khordha ORISSA pediatrics Sector 4E, Kalamboli, Navi Mumbai Mumbai MAHARASHTRA Community Medicine Mandya Institute of Medical Sciences Mandya KARNATAKA C-3/63A,Yamuna Vihar New Delhi sinchabhi@yahoo.com sonsam72@yahoo.co.u k nimain.mohanty@gmail.com mahendrabj@gmail.co m page 2 / 7

3 Details of Ethics Committee Dr Manish Mannan Dr Tapan Shah Dr P K Purthi Dr Satyajit Mahapatra Paras Hospital, Guragon Sangini Hospital, Ahmedabad Sir Ganga Ram Hospital, Delhi SRM Medical College Hospital & Research Centre, Chennai DELHI C1, Sushant Lok, Phase 1, Bahadurgarh Gurgaon HARYANA 2nd floor sangini complex Near doctor house Parimal crossing Ahmadabad GUJARAT R-503, Pediatrics Sir, Gangaram Hospital Marg, Rajinder Nagar New Delhi DELHI Pediatrics SRM University, Potheri, Kattankulathur Chennai TAMIL NADU vkgoyal22@gmail.com manishmannan@yahoo.com drtapansah@rediffmail. com pkpurthi@hotmail.com satyajit_mp@yahoo.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee Inmdar Multi specialty Hospital, Pune Ethics Committee, Paras Hospitals. Gurgaon Institute of Child Health, Kolkata Institutional Ethics Committe, Meenakshi Mission Hospital, Madhurai Institutional Ethics committee, King George Hospital, Vishakapatnam Institutional Ethis Committee, JSS Medical Collage, Mysore Jasleen hospitals Ethics committee, Nagpur Jasleen hospitals Ethics committee, Nagpur Jasleen hospitals Ethics committee, Nagpur Kalinga Institute of Medical Sciences, Orissa KLE university, Belgaum Approved 16/04/2014 No Approved 26/03/2014 No Approved 30/04/2014 No Approved 21/07/2014 No Approved 24/05/2014 No Approved 02/01/2014 No Approved 16/04/2014 No Approved 23/05/2014 No Approved 09/06/2014 No Approved 05/02/2014 No Approved 02/06/2014 No Mandya Institute of Approved 30/06/2013 No page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Medical Sciences MGM institute of health sciences, Navi Mumbai Panchsheel ethics committee Sangini Hospital Ethics Committee, Ahmedabad Searoc Ethics Commitee, Jaipur Sir Ganga Ram Hospital, Delhi SRM Medical Collage & Resarch Center, Chennai Status Approved 04/04/2014 No Approved 22/04/2014 No Approved 17/04/2014 No Approved 03/06/2014 No Approved 29/04/2014 No Approved 09/01/2014 No Date Approved/Obtained 24/03/2014 Health Type Healthy Human Volunteers Condition Severe Rotavirus Gastroenteritis Type Details Comparator Agent ROTAVAC SPG Liquid Vaccine 0.5mL will be administered orally as three doses on day 0, day 28±2 and day 56±2. with 5 minutes prior administration of 2.5 ml of buffer Intervention ROTAVAC SPG Liquid Vaccine 0.5mL will be administered orally as three doses on day 0, day 28±2 and day 56±2. without buffer Intervention ROTAVAC SPG Liquid Vaccine 0.5mL will be administered orally as three doses on day 0, day 28±2 and day 56±2. immediately mixed with 2.5 ml of buffer prior administration. 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 of at least 3kg at birth. 4.Infants received EPI vaccines at birth. 5.Parental ability and willingness to provide informed consent and possible to contact on Phone. 6.Parent who intends to remain in the area with the child during the study period. Exclusion Criteria Details Exclusion Criteria 1.Presence of diarrhoea 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.Acute disease at the time of enrolment (temporary exclusion). page 4 / 7

5 4.Concurrent participation in another clinical trial throughout the entire timeframe of this study. 5.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. 6.History of congenital abdominal disorders, intussusception, abdominal surgery 7.Known or suspected impairment of immunological function based on medical history and physical examination. 8.Household contact with an immunosuppressed individual or pregnant woman. 9.Prior receipt of rotavirus vaccine. 10.A known sensitivity or allergy to any components of the study medication. 11.Major congenital or genetic defect. 12.History of persistent diarrhoea (defined as diarrhoea more than 14 days). 13.Participant s parents not able, available or willing to accept active weekly follow-up by the study staff. 14.Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. 15.History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 16.History of any neurologic disorders or seizures. 17.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 participant s parent s/legally acceptable representative s ability to give informed consent. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Participant Blinded Primary Outcome Outcome Timepoints To evaluate the Immunogenicity of a 3-dose series of ROTAVAC administered orally to prevent severe rotavirus gastroenteritis in healthy n infants. Day 0, day 84±7 Secondary Outcome Outcome Timepoints Occurrence of solicited symptoms, any grade 2 or 3 fever, vomiting,diarrhoea, unsolicited adverse events and serious adverse events 1.Seroresponses in at least 50% of recipients in all the groups 2.Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination 3.Occurrence of unsolicited AEs for each infant in the entire cohort will be carried out over the period between first vaccination and 28 days after the third vaccination 4.Occurrence of SAEs over the period between vaccination 5.Occurrence of vaccine-related SAEs over the entire duration of the study page 5 / 7

6 Target Sample Size Phase of Trial Phase 4 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 Total Sample Size=900 Sample Size from =900 01/05/2014 No Date Specified Years=0 Months=10 Days=0 Not Applicable Completed It is not clear how rotaviruses, given their acid liability, are nevertheless so efficient in causing virtually ubiquitous infection in mammals, many of which have a range of gastric ph values from 1 to 2. However, the human infant stomach may be somewhat more permissive for survival of rotavirus than the adult stomach, as infant gastric ph levels tend to be approx. 3.2 compared with adults at approximately 1.0. This could account for the fact that 60 to 90~ of reported human rotavirus disease occurs in children below the age of 3 years. The fact that the ph within the stomach remains above 3 for at least 1 h after eating a meal might also help to explain the efficient transmission of rotavirus in mammals. Nevertheless, the possibility that rotavirus vaccination efficiency may be increased by either selection of acid resistant variant virus populations or by artificially neutralizing stomach acidity prior to administration of vaccine merits further study. 1. The study is designed as a multicenter, single-blinded, randomized, trial with three groups of infants to assess the immunogenicity and safety of three doses of ROTAVAC containing NLT Log 10 5 fluorescent focus units (FFU)/ Dose of virus when administered after 5 minutes, without and simultaneously with antacid at 4 weeks intervals between doses (with a window of +2 weeks). The first administration will occur at 6-8 weeks of age. 2. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination will be conducted all the infants. ( Reactogenicity ) 3. Surveillance for unsolicited AEs for each infant in the entire cohort will be carried out over the period between first vaccination and 28 days after the third vaccination. 4. Surveillance for all SAEs over the period between first vaccination and all three doses will be conducted for all participants. page 6 / 7

7 Powered by TCPDF ( 5. Surveillance for vaccine-related SAEs over the entire duration of the study will be conducted on all participants page 7 / 7