PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 11:40:56 GMT) CTRI Number CTRI/2020/11/029234 [Registered on: 19/11/2020] - Trial Registered Prospectively Last Modified On 30/06/2021 Post Graduate Thesis No Type of Trial Interventional Type of Study Vaccine Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Multi-centre, phase II/III adaptive clinical trial to assess safety and immunogenicity of Gam-COVID-Vac combined vector vaccine Scientific Title of Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Study Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS- Cov-2 Infection in Indian Healthy Subjects Secondary IDs if Any Secondary ID Identifier RDI-GCV-001 V3.0 dated 19 Oct 2020 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Agam Shah Trial Coordinator (multi-center study) Designation Lead, Clinical & Medical Operations Affiliation Dr. Reddy’s Laboratories Limited Address Integrated Product Development Office, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090, Telangana, India Hyderabad TELANGANA 500090 India Phone 9963164410 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sonika Newar Query) Designation Deputy General Manager-Medical Monitoring and Safety Affiliation JSS Medical Research Asia Pacific Private Limited Address Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India Faridabad HARYANA 121003 India Phone 08800799887 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Shariq Anwar Designation Head Operations - Monitoring & Site Management Affiliation JSS Medical Research Asia Pacific Private Limited Address Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India Faridabad page 1 / 10 PDF of Trial CTRI Website URL - http://ctri.nic.in HARYANA 121003 India Phone 9810979215 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Dr. Reddy’s Laboratories Limited, Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090 Primary Sponsor Primary Sponsor Details Name Human Vaccine LLC Address Capital City, South Tower, 8, Building. 1, Floor 7, Room I, part of Room 3, workstation 7.31, Presnenskaya Naberezhnaya, 123112, Russia Type of Sponsor Government funding agency Details of Secondary Name Address Sponsor Dr Reddys Laboratories Limited Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal, Malkajgiri District, Hyderabad – 500090 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr P Naveen Reddy AIG Hospitals AIG Hospitals, No. 136, 919848045814 Plot No 2/3/4/5 Survey, 1, Mindspace Rd, drnaveen.reddy@aigho Gachibowli, Hyderabad, spitals.com Telangana 500032 Hyderabad TELANGANA Dr Sandeep Kumar Atharva Multispecialty H-4/ Comm-2, 9336077839 Gupta Hospital & Research Construction Div-21, UP Avas Vikas atharva.hospital@gmail Parishad Sector E, .com Lucknow-226003 Lucknow UTTAR PRADESH Dr Rohidas Borse B. J. Government B. J. Government 919923912525 Medical College & Medical College & Sassoon General Sassoon General [email protected] Hospital Hospital, Department of Medicine, 3rd floor, B J Government Medical College & Sassoon General Hospital Jayaprakash Narayan Road, Near Railway Station, Pune - 411001, Maharashtra, India Pune MAHARASHTRA Dr Parshottam Koradia BAPS Pramukh Swami BAPS Pramukh Swami 919825312027 Hospital Hospital Shri Pramukh page 2 / 10 PDF of Trial CTRI Website URL - http://ctri.nic.in Swami Maharaj Marg, purushottam_koradia@ Adajan Chaar rasta, yahoo.co.in Surat - 395009 Surat GUJARAT Dr Suninder Singh Batra Hospital and Room No 15, Block B, 919810113414 Arora Medical Research Department of Medicine Centre and Critical Care [email protected] Medicine, Batra Hospital and Medical Research Centre, 1 Tughlakabad Institutional Area Mehrauli-Badarpur Road, New Delhi-110062 South DELHI Dr Winsley Rose Christian Medical Department of 09698884466 College Vellore Pediatrics (Unit-3) ISSCC Building, Ida winsleyrose@cmcvellor Scudder Road, e.ac.in Christian Medical College Vellore- 632004, Vellore TAMIL NADU Dr Arindam Ray College of Medicine & College of Medicine & 916291141797 Sagore Dutta Hospital Sagore Dutta Hospital, 578, B.T. Road, [email protected] Kamarhati, om Kolkata-700058, West Bengal Kolkata WEST BENGAL Dr Asim Das ESIC Medical College NH-3, NIT Faridabad - 07838182228 and Hospital 121001, Haryana Faridabad [email protected] HARYANA c.in Dr Saurabh Agarwal GSVM Medical College Post Graduate 09415039582 Department of Medicine GSVM Medical College, dragarwalsaurabh@gm Swaroop Nagar, ail.com Kanpur - 208002, Uttar Pradesh Kanpur Nagar UTTAR PRADESH Dr Sunil Kohli Hamdard Institute of Hamdard Institute of 919873351206 Medical Science & Medical Science & Research with Centre Research (HIMSR) with [email protected] for Health Research Centre for Health om and Development Research and Development – Society for Applied studies (CHRD-SAS) [HIMSR with CHRD-SAS] Guru Ravidas Marg, Hamdard Nagar, New Delhi – 110062 South page 3 / 10 PDF of Trial CTRI Website URL - http://ctri.nic.in DELHI Dr Viny Kantroo Indraprastha Apollo Indraprastha Apollo 919811120777 Hospitals Hospitals, Apollo Research and [email protected] Innovation Nursing Hostel Complex, Basement Indraprastha Apollo Hospitals, Delhi Mathura Road Sarita Vihar, New Delhi 110076, India New Delhi DELHI Dr Shilpa Avarebeel JSS Hospital Department of 09880053998 Geriatrics JSS Hospital, Mahatma Gandhi Road, shilpaavarebeel@gmail. Mysore-570004, com Karnataka Mysore KARNATAKA Dr Anand Kawade KEM Hospital Research Vadu Rural Health 09850559983 Center Program, P. O. Vadu (Budruk), Taluka Shirur, anand.kawade@kemhr Dist Pune – 412216, cvadu.org Maharashtra Pune MAHARASHTRA Dr Jayaprakash KLE’s Dr Prabhakar Department of Medicine 09844595659 Appajigol Kore Hospital and MRC KLEs Dr. Prabhakar Kore Hospital and jayaprakashappajigol@ MRC, Nehru Nagar, gmail.com Belgavi-590010, Karnataka Belgaum KARNATAKA Dr Manish Kumar Jain Maharaja Agrasen Central Spine, Agrasen 9414414834 Superspecialty Hospital Aspatal Marg, Sec 7 Vidyadhar Nagar, doctormanishjain2@gm Jaipur - 302039 ail.com Jaipur RAJASTHAN Dr Anand Nikalje MGM Medical College MGM Medical College 919890840086 & Hospital & Hospital, N-6, CIDCO, Aurangabad – dranandnikalje68@gma 431003, Maharashtra il.com Aurangabad MAHARASHTRA Dr Sidram Raut Noble Hospitals Pvt. 153, Magarpatta City 9423581029 Ltd. Road, Hadapsar, Pune - 411013 Maharashtra [email protected] India .uk Pune MAHARASHTRA Dr Subhrojyoti Peerless Hospitex Peerless Hospitex 919830204863 Bhowmick Hospital and Research Hospital and Research Centre Ltd. center Ltd, 360, [email protected] Panchasayar, Kolkata-700094 Kolkata page 4 / 10 PDF of Trial CTRI Website URL - http://ctri.nic.in WEST BENGAL Dr Anil Purty Pondicherry Institute of Department of 09442233460 Medical Sciences Community Medicine Pondicherry Institute of [email protected] Medical Sciences (Unit of Madras Medical Mission), Basic Sciences Block, Village no. 20, Ganapathychettikulam, Kalapet - 605014, Puducherry Pondicherry PONDICHERRY Dr Nirav Bhalani Rhythm Heart Institute Rhythm Heart Institute 918128995863 Near Siddharth Bungalows, Sama Savli drniravbhalani@hotmail Road Vadodara 390022 .com Vadodara GUJARAT Dr Prabhat Kumar SN Medical College SN Medical College, 919319250485 Agrawal Central Library, Moti Katra, Mantola, Agra, [email protected] Uttar Pradesh – om 282-003 Agra UTTAR PRADESH Dr Akash Khobragade St. Georges Hospital P D Mello Rd, opposite 09702658822 GPO, beside CST station, Chhatrapati drakashk.research@gm Shivaji Terminus Area, ail.com Fort, Mumbai, Maharashtra 400001 Mumbai MAHARASHTRA Dr Arti Shah Sumandeep Vidyapeeth Sumandeep Vidyapeeth 919925047880 an Institution Deemed an Institution Deemed to be University & to be University & [email protected] Dhiraj Hospital Dhiraj Hospital, At & Po m Piparia, Ta. Waqhodia, Vadodara 391760 Vadodara GUJARAT Dr Abhishek Agarwal The INCLEN Trust The INCLEN Trust 919582366630 International Guru International, Guru Nanak Hospital Nanak Hospital, abhishek.agarwal@incl Opposite Palwal Bus entrust.org Stand, Main Delhi Mathura Road, (National Highway 2) Palwal, Haryana - 121102 Faridabad HARYANA Dr K Shantaraman Tirunelveli Medical Tirunelveli Medical 919443133898 College College, North Highground, [email protected] Tirunelveli-627011, c.in Tamilnadu, India page 5 / 10 PDF of Trial CTRI Website URL - http://ctri.nic.in Tirunelveli TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 12/11/2020 No Committee, Maharaja Agrasen Hospital, Jaipur Ethics Committee Approved 13/11/2020 No GSVM Medical