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CTRI Number  CTRI/2021/01/030416 [Registered on: 12/01/2021] Trial Registered Prospectively
Last Modified On: 01/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects. 
Scientific Title of Study   A phase III, randomized, multi-centre, double blind, placebo controlled, study to evaluate efficacy, safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited. 
Trial Acronym  ZyCoV-D 
Secondary IDs if Any  
Secondary ID  Identifier 
NCOV.20.002,Version 03, dated 08 January 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravindra Mittal  
Designation  Senior Vice President  
Affiliation  Cadila Healthcare Limited  
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway.

Ahmadabad
GUJARAT
382481
India 
Phone  07948040000  
Fax    
Email  r.mittal@zyduscadila.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kevinkumar Kansagra 
Designation  General Manager 
Affiliation  Cadila Healthcare Limited  
Address  Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya,

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax    
Email  kevinkumarkansagra@zyduscadila.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravindra Mittal  
Designation  Senior Vice President  
Affiliation  Cadila Healthcare Limited  
Address  Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway.

Ahmadabad
GUJARAT
382213
India 
Phone  02717665555  
Fax    
Email  r.mittal@zyduscadila.com  
 
Source of Monetary or Material Support  
Cadila Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad 
 
Primary Sponsor  
Name  Cadila Healthcare Ltd  
Address  Zydus Corporate Park, 3rd Floor B Wing (NPD), Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad – 382 481, 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 59  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Langade  DR. D.Y.Patil Medical College and Hospital  5th Floor Department of Pharmacology, College building, DR. D.Y.Patil Medical College and Hospital, Nerul Sector 5 Navi Mumbai- 400706.
Mumbai
MAHARASHTRA 
2227735999

deepak.langade@dypatil.edu 
Dr Himanshu Pophale  Ace Hospital  Sr. No 32/2A, Erandawane Gulwani Maharaj Road, Near Abhishek Hotel, Pune, Mh, 411004
Pune
MAHARASHTRA 
2025434063

himanshupophale@yahoo.co.in 
Dr Vijay Shukla  Ajanta Research Centre  Ajanta Hospital & IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226005
Lucknow
UTTAR PRADESH 
9839093246

dr.vijayshukla@yahoo.com 
Dr Pankaj Bharadwaj  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Jodhpur-342005, Rajasthan India
Jodhpur
RAJASTHAN 
2912740741

pankajbhardwajdr@gmail.com 
Dr Vipul Khandelwal  Apex Hospital Pvt. Ltd  SP 4& 6 MIA Malviya Nagar near apex circle, Jaipur-302017
Jaipur
RAJASTHAN 
0141-2751871

dr.vipul@yahoo.co.in 
Dr Venkatasubramanian  Apollo Hospitals  Greams Road No. 21, Greams Lane, Off. Greams Road, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU 
4428295045

idisdoc@gmail.com 
Dr Ravindra Mehta  Apollo Speciality Hospitals Jayanagar  , Old Number 21/2, New Number 2, 14th Cross, 3rd Block, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA 
8026304017

Reetesh.singh@trialguna.com 
Dr Anupam Kumar  Arogya Hospital  Plot NH-1, Vaishali sector-6, Vaishali, Ghaziabad, Uttar Pradesh-201010
Ghaziabad
UTTAR PRADESH 
9811817617

aarogyaclinicalresearch@gmail.com 
Dr Shrikant Deshpande  Ashirwad Hospital  Next to Jijamata Udyan, Maratha Section 32, Krishna Nagar, Ulhasnagar, Maharashtra 421004
Thane
MAHARASHTRA 
02512587493

shrikant@rediffmail.com 
Dr Sandeep Kumar Gupta  Atharva Multispeciality Hospital & Research Centre  H-4/Comm-2, construction Div-21, UP Avas Vikas Parishad, Sector E, Lucknow-226003
Lucknow
UTTAR PRADESH 
9336077839

sandeepkumr.gupta@rediffmail.com 
Dr Animesh Choudhary  Balco Medical Centre  Sector 36, Atal Nagar, Uparwara,New Raipur-493661,Chhattisgarh, India
Raipur
CHHATTISGARH 
7712237575

dranimeshc@gmail.com 
Dr Parshottam Koradia  BAPS Pramukh Swami Hospital  Shri Pramukh Swami Maharaj Marg, Adajan char rasta. Adajan. Surat - 395 009 Gujarat, India
Surat
GUJARAT 
9825312027

purushottam_koradia@yahoo.co.in 
Dr Bhaskar Vilasrao Jedhe Deshmukh   Baramati Hospital Pvt. Ltd.  Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati 413102
Pune
MAHARASHTRA 
9822402772

bhaskar.jedhe@gmail.com 
Dr Sanjay Lalwani  Bharati Vidyapeeth (Deemed To Be University)  Medical College and Hospital, Pune- 411043, Maharashtra, India
Pune
MAHARASHTRA 
9373314322

sanjaylalwani2007@rediffmail.com 
Dr Krishna Giri  Dhadiwal Hospital Research department  4th floor, Trambakeshwar Rd, Opp. New, CBS, Matoshree Nagar, Nashik, Maharashtra 422002, India.
Nashik
MAHARASHTRA 
02532578457

drkmgiri@gmail.com 
Dr Rohit Jain  DIVINE Multispecialty Hospital and Cancer Centre  DIVINE Multispecialty Hospital and Cancer Centre, Wazirabad, Delhi
New Delhi
DELHI 
9212410444

devinehospiresearch@gmail.com 
Dr Swapnav Borthakur  Downtown Hospita  Dispur, G S Road, Guwahati-781006
Kamrup
ASSAM 
3612331003

swpnav.borthakur@gmail.com 
Dr Sharad Agarkhedkar   Dr. D Y Patil Medical College  Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune - 411018, Maharashtra, India
Pune
MAHARASHTRA 
2067116412

ashalaka@gmail.com 
Dr Mahamine Kaustubh Suryakant  Dr. Vasantrao Pawar Centre For developmental Therapeutics Translational Research  4th floor near MRD section in Medical College, Dr. Vasantrao Pawar Medical College, Hospital and Research Centre, Vasantdada Nagar, Adgaon, Nashik - 422003, Maharashtra, India
Nashik
MAHARASHTRA 
0253-220500

drkastubhmahamine@gmail.com 
Dr Dharmendra Kumar Gupta  Felix Hospital  A Unit Of Felix Healthcare Pvt Ltd ,NH 01 Sector 137 Noida (India) - 201305
New Delhi
DELHI 
9695239796

FELIXHOSPITALRESEARCH@gmail.com 
Dr Manoj Kumar  Flores Hospital  NH-1, Block G, Sec-11 Pratap Vihar, Ghaziabad, Uttar Pradesh-201009
Ghaziabad
UTTAR PRADESH 
7877110499

drmanoj73kumar@gmail.com 
Dr Parul Bhatt  GMERS Medical College and Civil Hospital Sola  Nr. Gujarat High Court, S. G. Highway, Sola, Ahmedabad 380060, Gujarat, India
Ahmadabad
GUJARAT 
9879599595

parulbhatt30@yahoo.com 
Dr Akash Khobragde  Grant Government Medical College & sir J.J Group of hospital  Grant Government Medical College & sir J.J Group of hospital, Byculla, Mumbai 400008
Mumbai
MAHARASHTRA 
23735555

akash.khobragade@gmail.com 
Dr Saurabh Agrawal  GSVM Medical College  "GSVM Medical College, Swaroop Nagar, Kanpur- 208002 "
Kanpur Nagar
UTTAR PRADESH 
5122535483

saurabh.gsvmmed@gmail.com 
Dr Shiva Narang  Guru Teg Bahadur Hospital and UCMS  Dilshad Garden, Delhi 110095
East
DELHI 
9899838807

shivanarang@gmail.com 
Dr Rajnish Nagarkar  HCG Manavata Cancer Centre  Behind Shivang Auto, Mubai Naka, Nashik,Pin- 422101,Maharashtra,India
Nashik
MAHARASHTRA 
9823061929

drraj@manavatacancercentre.com 
Dr Sandeep Jain  Imperial Hospital & Research Center  Department of General Medicine, Shastri Nagar, Jaipur-302016, Rajasthan, India
Jaipur
RAJASTHAN 
9414069583

drsandeeprjain@yahoo.co.in 
Dr Monjori Mitra  Institute of Child Health  Institute of Child Health, 11, Dr Biresh Guha Street, Kolkata – 700017
Kolkata
WEST BENGAL 
9831075734

monjorimr@gmail.com 
Dr Suresh Bhate  Jeevan Rekha Hospital,  Dr. B.R. Ambedkar Road, Opp. Civil Hospital, Belagavi (Belgaum), Karnataka – 590002
Belgaum
KARNATAKA 
0831-4215593

drsureshgbhate@gmail.com 
Dr Veer Bahadur Singh  JLN Medical College  Kala Bagh, Ajmer 305001
Ajmer
RAJASTHAN 
1452425050

vbsingh2@rediffmail.com 
Dr Satyanarayan Sharma  Kasturi Das Memorial Superspeciality Hospital  Govt Colony, Block-B, Mollar Gate, Santoshpur, Kolkata, West Bengal 700142
Kolkata
WEST BENGAL 
3324320043

satyanarayansharma10@gmail.com 
Dr Vijendra R  KIMS Medical College Hospital  Athibabbe Road, 30th Main Road, Near BDA Shopping Complex, Banashankari Stage II, Banashankari, Bengaluru, Karnataka – 560070
Bangalore
KARNATAKA 
26624870

vijendra_ramaiah@yahoo.co.in 
Dr Rajendra Bapusaheb Nerli  KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Department of Urology, J. N. Medical College, KLE Academy of Higher Education & Research,(Deemed-to-be-University), JNMC Campus, Belagavi- 590010, Karnataka
Belgaum
KARNATAKA 
8312444444

rajendranerli@yahoo.in 
Dr Sreedevi A  Kurnool Medical College and Governement General Hospital  Bhudawarapet Bharath Petroleum, Kisan Ghat Rd, Kurnool, Andhra Pradesh 518002
Kurnool
ANDHRA PRADESH 
8518255160

sreedevispm@gmail.com 
Dr Manish Kumar Jain   Maharaja Agrasen Superspeciality Hospital, Central Spine  Agrasen Aspatal Marg, Sector -7, Vidyadhar Nagar, Jaipur - 302039, Rajasthan, India
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr N Srinivasa Rao  Malla Reddy Narayana Multispeciality Hospital,   Suraram X Road, Jeedimetla, Suraram, Hyderabad, Telangana, 500055
Hyderabad
TELANGANA 
9440235092

drnanyam@yahoo.com 
Dr K M Shivkumar   Mandya Institute of Medical Science  Bangalore-Mysore Road, Mandya, Karnataka - 571401
Mandya
KARNATAKA 
8213989896

mims@gmail.com 
Dr Inderjeet Godara  Marudhar Hospital  A-93-99, Singh Bhoomi Khatipura Road Jaipur Jaipur Rajasthan - 302012 India
Jaipur
RAJASTHAN 
9829065657

inder72@gmail.com 
Dr Dinesh Agrawal  Marwari Hospitals,  S.J Road, Athgaon, Guwahati, Assam-781008
Kamrup
ASSAM 
0361-2602738

drdinesh944@gmail.com 
Dr Manjunath PH  Mazumdar Shaw Medical Centre  Clinical Research Department,258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099, India
Bangalore
KARNATAKA 
8071222222

Manjuph.vims@gmail.com 
Dr Tanmay Banerjee  Medica Super Speciality Hospital  127 Mukundapur, E.M. Bypass, Kolkata, WB- Pin 700099
Kolkata
WEST BENGAL 
3366520000

tanmay.banerjee@medicasynergie.in 
Dr Ramesh Revana  N R R Hospital  Janapriya Apartments, No.3&3A, Hesarghatta Main Road, Chikkasandra, Next to, Geleyara Balaga Layout, Jalahalli West, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA 
9341229228

ramesh2reva@yahoo.com 
Dr Sanjay Kantilal Shah   Narayana Superspeciality Hospital  120/1, Andul Road, Howrah-711103, West Bengal, India.
Haora
WEST BENGAL 
18602080208

diabetesdrshah@gmail.com 
Dr Tanmay Mandal  Netaji Subhash Chandra Bose Cancer Hospital  Department of Clinical Research, 3081, Nayabad, New Garia, Kolkata-700094, West Bangal., India
Kolkata
WEST BENGAL 
3324320043

tanmoy.nrs@gmail.com 
Dr Anjan Bera  Nil Ratan Sircar Medical College and Hospital  138. Acharya Jagadish Chandra Bosce Rd, Sealdah, Kolkata- 700014,WB
Kolkata
WEST BENGAL 
03322860033

anjanbera78@gmail.com 
Dr N Ravi kumar  Niloufer Hospital  Redhills, Lakdikapul, Hyderabad, Telangana- 50000
Hyderabad
TELANGANA 
9490919293

ravik1961@yahoo.com 
Dr Jay Soni  Parth Orthopedic & Surgical Hospital  E405-4, 411 Galaxy Arcade, Galaxy Cinema Road, Noroda, Ahmedabad, Gujarat 382330, India.
Ahmadabad
GUJARAT 
9898003433

mrdrjaysoni@gmail.com 
Dr Prashant Khandgave  Pulse Multispeciality Hospital  Sr. No. 51/7/B/1, Vishwa Arcade Bombay Banglore Highway, Narhe, Pune 411041, Maharashtra
Pune
MAHARASHTRA 
8048034653

prashantkhandgave@yahoo.in 
Dr Manish Hathila  Sai Krupa Hospital  ,F- 30 31, Satyam Status, Opp. Chandan Party Plot,Anandnagar- Ramdevnagar Road, Ahmedabad 380053
Ahmadabad
GUJARAT 
07926870423

manishathila@gmail.com 
Dr Raman Sharma  SMS hospital  JLN Marg, Ashok Nagar, Jaipur – 302001, Rajasthan
Jaipur
RAJASTHAN 
1412385052

sharmarm@gmail.com 
Dr Srinivasa Murthy  Sri Siddhartha Medical College  VISHVAMBARA 2nd Main, G.P Rajaratnam Road Saraswathipuram, Tumkur -572102
Tumkur
KARNATAKA 
8162278867

ssmc@clinisydresearch.com 
Dr A Venkateshwar Rao  St. Theresa Hospital  St. Theresa Hospital, Sanathanagar, Hyderbad-500018, Telangana
Hyderabad
TELANGANA 
4023704411

drvenkateshwarraoavula@gmail.com 
Dr Pravin Supe  Supe Hospital  Gharapure Ghat Rd, near Rungta High School, Ashok Stambh, Raviwar Karanja, Panchavati, Nashik, Maharashtra 422002
Nashik
MAHARASHTRA 
02532232487

pravinsupe@yahoomail.com 
Dr Kulandaivel  Thangam Hospital and Thangam Cancer Center  No.54, Dr.Sankaran Road, Namakkal, Tamil Nadu – 637001
Namakkal
TAMIL NADU 
9043030685

dr.r.kulandaivel@gmail.com 
Dr Renuka Munshi  TN Medical College & BYL Nair Hospital  Department of Clinical Pharmacology, G building, 5th Floor, Mumbai-400008
Mumbai
MAHARASHTRA 
02223027204

renuka.munshi@gmail.com 
Dr Samir Gami  Unique Hospital- Multispecialty & Research Institute  Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002, Gujarat, India.
Surat
GUJARAT 
9925276708

samirgami.dr@gmail.com 
Dr Ramakrishna Chinta  Vendanta Hospital  Near Best Price, Mangalagiri Road, Guntur, AP 522001
Guntur
ANDHRA PRADESH 
7793903754

vedantahospitals1@gmail.com 
Dr Hari Shankar Gupta  VIMS Hospital  Kamptee Rd, LIC Square, Mohan Nagar, Nagpur, Maharashtra 440001
Nagpur
MAHARASHTRA 
7212811400

drhari_gupta@yahoo.com 
Dr Kalpesh Talati  Zydus Hospitals and Healthcare Research Pvt Ltd  Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054
Ahmadabad
GUJARAT 
9824014187

kalpeshtalati@zydushospitals.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 59  
Name of Committee  Approval Status 
"Apollo Hospital Institutional Ethics Committee- Clinical, 154/11, opp.IIM Bannerghatta Road Bengaluru, Bengaluru (Bangalore) Urban Karnataka-560076 "  Approved 
"Clinical Research Ethics Committee Medica Superspecialty Hospital ,127, Mukundapur E.M.Bypass Kolkata (India) - 700099 India"  Approved 
"Ethics Committee, N.R.S Medical College 138, Acharya Jagadish Chandra Bose Road, Sealdah, Kolkata, 700014, West Bengal, India"  Approved 
"Ethics Committee,N.S.C.B.C. Research Institue, 3081, Nayabad, New Garia, Kolkata 700094"  Approved 
"IEC Columbia Asia Hospital Mysore IEC CAH columbia Asia Hospitar Mysore ,No. 85-86, Bangarore Mysore Ring Road Junction, Bannimantapa A Layout, Siddiqui Nagar, Mysuru-570015"  Approved 
"Instituional Ethics Committee of Vidharba Institute of Medical Sciences, Mohan Nagar, LIC Square, Kamptee Road, Nagpur, Maharashtra 440001 "  Approved 
"Institutional Ethics Committee Guru Teg Bahadur Hospital , Dilshad Garden, Delhi 110095 "  Approved 
"INSTITUTIONAL ETHICS COMMITTEE Kurnool Medical College/Government General Hospital Budhawarpet, Kurnool Andhra Pradesh - 518002 India"  Approved 
"Institutional Ethics Committee, Dr. Vasantrao Pawar Medical College, Hospital and Research Centre, Maharashtra - 422003, India "  Approved 
"Institutional Ethics Committee, GMERS Medical College and Civil Hospital Sola, Department of Pharmacy, 4th floor college building, Nr. Gujarat High Court, S. G. Highway, Sola, Ahmedabad 380061, Gujarat, India "  Approved 
"Manavata Clinical Research Institute Ethics Committee Opposite Mahamarg Bus Stand, Mumbai Naka, Nashik – 422004 Maharashtra, India "  Approved 
"Shree Instituional Ethics Comiittee Dhadiwal Hospital Research department. 4th floor, Trambakeshwar Rd, Opp. New, CBS, Matoshree Nagar, Nashik, Maharashtra 422002, India."  Approved 
AMAI Trust ACE Hospital IEC, 8/4/1, Yashwant apt, Shop No 7, Lane No 4, Karve Nagar, Pune-411052, Maharashta, India  Approved 
Ashirwad Ethics Committee, Maratha Section, Near Jijamata Udyan, Ulhasnagar, Maharashtra 421004  Approved 
BAPS Pramukh Swami Hospital Ethics Committee, BAPS Pramukh Swami Hospital, Adajan Cross Road. Adajan. Surat-395009  Approved 
Ethics Committee - Dr. D Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune - 411018, Maharashtra, India.  Approved 
Ethics Committee Baramati Hospital Pvt. Ltd., Baramati Hospital Pvt. Ltd., Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati 413102  Approved 
Ethics Committee Downtown Hospital, Dispur, G S Road, Guwahati-781006  Approved 
Ethics committee of Pulse Multispeciality Hospital, Pulse Multispeciality Hospital, Sr. No. 51/7/B/1, Vishwa Arcade Bombay Banglore Highway, Narhe, Pune 411041, Maharashtra  Approved 
Ethics Committee of SMS Medical College & Attached Hospital, Office of Ethics Committee, Second Floor, New Administration Block, SMS Medical College, JLN Marg, Jaipur-302004, Rajashthan  Approved 
Ethics Committee Unique Hospital- Multispecialty & Research Institute, Opp. Kiran Motor, Nr. Canal, Civil Hospital Char Rasta- Sosyo Circle Lane, Off Ring Road, Surat- 395002, Gujarat, India  Approved 
Ethics Committee, GSVM Medical College, Room No 125, First Floor, GSVM Medical College, Swaroop Nagar, Kanpur-208002  Approved 
Ethics Committee, N.S.B.C Research Institute, 3081, Nayabad, New Garia, Kolkata-700094  Approved 
Ethics Committee, Sanjeevani cancer Hospital, Sanjeevani CBCC USA Cancer Hospital in front of Jain Mandir, Dawada Colony Pachpedi Naka, Raipur-492001  Approved 
Ethics Committee, St. Theresas Hospital, Sanathnagar, Hyderabad-500018, Telangana, India  Approved 
IEC Maharaja Agrasen Hospital, Central Spine, Agrasen Aspatal Marg, Sector -7, Vidyadhar Nagar, Jaipur - 302039, Rajasthan, India  Approved 
Instituiional Ethics Committee, Ajanta Research Centre, Ajanta Hospital & IVF Centre, 765, ABC Complex, Kanpur Road, Alambagh, Lucknow-226005  Approved 
Instituiional Ethics Committee, Atharva Multispeciality Hospital & Research Centre, H-4/Comm-2, construction Div-21, UP Avas Vikas Parishad, Sector E, Lucknow-226003  Approved 
Instituional Ethics Committee, Jeevan Rekha Hospital, Dr. B R Ambedkar Road Belgavi-590002  Approved 
Instituional Ethics Committee, Sri Siddharta Medical College and Research Centre, B.H Road, Agalkote, Tumkur, Karnataka-572107  Approved 
Instituional Ethics Committee,GGMC Mumbai, Grant Government Medical College, J.J Road, J.J Hospital Compund, Mumbai Central, Mumbai, Mumbai City, Maharashtra, Mumbai-400008.  Approved 
Institutional Ethics Committee Apex Hospital Pvt. Ltd, Sp 4 & 6 MIA Malviya Nagar, near apex circle, Jaipur-302017  Approved 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University, Institutional Ethics Committee Office, 4th floor, Bharati Hospital and Research Centre, Pune-Satara Road, Dhankawadi, Pune - 411043, Maharashtra, India.  Approved 
Institutional Ethics Committee Felix Hospital, Sector 137, Noida, Uttar Pradesh - 201305  Approved 
Institutional Ethics Committee for Academic Research Projects(ECARP), G Building, 4th Floor, T N Medical College & BYL Nair, Hospital, Dr. AL Nair Road, Mumbai Central, Mumbai-400008  Approved 
Institutional Ethics Committee ICH, Institute of Child Health, 11, Dr. Biresh Guha Street Kolkata Kolkata West Bengal - 700017 India  Approved 
Institutional Ethics Committee, DR. D.Y.Patil Medical College,Sector 5, Nerul, Navi Mumbai- 400706.   Approved 
Institutional Ethics Committee, KLE University, KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi, (Belgaum), Karnataka - 590010, India  Approved 
Institutional Ethics Committee, Osamania Medical College, Koti, Hyderabad, Telangana  Approved 
Institutional Ethics Committee-Clinical Studies, Apollo Hospitals,No. 21, Greams Lane, Off. Greams Road, Thousands Light, Chennai, Tamil Nadu 600006  Approved 
Institutional Ethis Committee for sehgal Nursing Home, A6, Panchwati, opp Azadpur New Subzi Mandi, Delhi-110033  Approved 
Institutional Ethis Committee for sehgal Nursing Home, A6, Panchwati, opp Azadpur New Subzi Mandi, Delhi-110033  Approved 
Institutional Ethis Committee for sehgal Nursing Home, A6, Panchwati, opp Azadpur New Subzi Mandi, Delhi-110033  Approved 
INSTITUTIONAL HUMAN ETHICS COMMITTEE, All India Institute of Medical Sciences, Basni Jodhpur Jodhpur Rajasthan - 342005 India  Approved 
Instiutional Ethics Committee, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer-305001, Rajashthan  Approved 
KIMS Instituional Ethics Committee, Kempegowada Institute Medical Sciences, Athibabbe Road,Banashankari 2nd Stage, Banashankari, Bengaluru, Urban, Karnataka – 560070  Approved 
Malla Reddy Medical College for women Ethics Committee, Suraram X Road, Jeedimetla, Suraram, Hyderabad, Telangana, 500055  Approved 
Marudhar Hospital Ethics Committee Marudhar Hospital A-93-99, Singh Bhoomi Khatipura Road Jaipur Jaipur Rajasthan - 302012 India  Approved 
Marudhar Hospital Ethics Committee Marudhar Hospital A-93-99, Singh Bhoomi Khatipura Road Jaipur Jaipur Rajasthan - 302012 India  Approved 
Marwari Hopitals, Sati Joymati Road Athgaon Guwahati Kamrup, Metropolitan Assam - 781008 India  Approved 
Naryana Health Medical ethics committee, 258/A Boomsandra Industrial Area, Hosur Road Anekal Taluk Bangalore 560099   Approved 
NSH Ethics Committee, NH-Narayana Superspeciality Hospital, 120/1, Andul Road, Howrah-711103, West Bengal, India.  Approved 
Parth Institutional Ethics Committee, Parth Orthopedic & Surgical Hospital, E408, Fourth Floor Galaxy Arcade, Near Galaxy Cinema, Naroda, Ahmedabad, Gujarat 382330, India.  Approved 
Pranav Diabetes Center Ethics Committee, 57/1, Nanda Complex Rammurthyanagar, Mainroad, banaswadi, Bangalore, Bengaluru(Bangalore) Urban, Karnataka-5460043   Approved 
Supe Hospital Ethics Committee, Opp Adhar Ashram, Near Runghta School, Gharpure, Ashok Stambh, Nashik-422002  Approved 
Thangam Hospital-Institutional Ethics Committee(TH-IEC), 54, Dr. Sankaran Road, Namakkal-637001, Tamilnadu, India  Approved 
Vedanta Hospital Institutional Ethics Committee, Vedanta Hospital ,Beside Vasavi Cloth Market,Mangalagiri Road Guntur (India) - 522001 India  Approved 
Vrajesh Hospital Institutional Review Board, opp Rajpath Club, Cargo Motors Lane, S.G Road, 117 Boadakdev, Ahmedabad- 380015  Approved 
Zydus Hospital Ethics Commitee Zydus Hospitals and Healthcare Research Pvt Ltd., Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Novel Corona Virus-2019-nCov Vaccine  (1)Dose:-0.2 ml (0.1ml in eacharms) with Pharmacjet (2)Site of administration:- Upper Arm (3)Frequency:-single time at day 0 day 28 and day 56. (4)Route:-Intradermal 
Comparator Agent  Placebo  1)Dose:-0.2 ml (0.1ml in eacharms) with Pharmacjet (2)Site of administration:- Upper Arm (3)Frequency:-single time at day 0 day 28 and day 56. (4)Route:-Intradermal 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Healthy subject of either gender ≥12 years of age.
2. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study.
3. Ability to provide informed consent from the adult subjects or from the parents of paediatric
subjects. Additionally, assent from paediatric subjects (Audio video recording in case of
vulnerable subject).
4. Adult subjects or parents of paediatric subjects literate enough to fill the diary card.
5. Subjects with good health or with stable medical condition for chronic disease. (Stable
condition is defined as there is no change in the medication or dose of medication or severity
of disease from last 3 months before enrolment.)
6. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical
sterilization), from screening until completion of the follow-up visit and males will agree to
use contraception.
7. Willing to allow storage and future use of biological samples for future research.
 
 
ExclusionCriteria 
Details  1.Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4
weeks of enrolment.
2. Laboratory confirmed SARS-CoV-2 positive.
3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days.
4. History of SARS/ MERS infection.
5. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine.
6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination.
7. Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation
therapy.
8. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on
any immunosuppressive or immunostimulant therapy.
9. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic,
gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological
disorder.
10. Subjects administered blood, blood containing products or immunoglobulins within the last
3 months or planned administration during the study.
11. Any other vaccine administration within the last 30 days or planned to be administered
during the study period.
12. Pregnant and lactating women.
13. Participation in another clinical trial in the past 3 months.
14. History of drug / alcohol abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.  Day 84 to Day 364  
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed
severe COVID-19 cases as compared to placebo 
Day 84, Day 186, Day 252, Day 364  
To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed
moderate COVID-19 cases as compared to placebo. 
Day 84, Day 186, Day 252, Day 364  
To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed mild
COVID-19 cases as compared to placebo. 
Day 84, Day 186, Day 252, Day 364  
To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed
asymptomatic COVID-19 cases as compared to placebo. 
Day 84, Day 186, Day 252, Day 364 
To demonstrate the efficacy of a ZyCoV-D in the prevention of virologically confirmed
COVID-19 death as compared to placebo. 
Day 84, Day 186, Day 252, Day 364 
To evaluate the immunogenicity by neutralizing antibody (nAb) assay in subset of
population. 
Day 0, Day 56, Day 84, Day 186, Day 252, Day 364 
To evaluate persistence of immunogenicity after first dose
of ZyCoV-D. 
Day 56, Day 84, Day 168, Day 252 and Day 364 
To evaluate the Lot-to-Lot consistency based on the IgG titer of the three consecutive lots used in the study.  At Day 84 
To evaluate safety and tolerability of ZyCoV-D.  Day 0 to Day 364 
 
Target Sample Size   Total Sample Size="28216"
Sample Size from India="28216" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in January, 2020.The virus is highly transmissible between humans and has spread rapidly, causing the COVID-19 pandemic. Patients infected with SARS-CoV-2, especially older patients and those with pre-existing respiratory or cardiovascular conditions are at greater risk for severe complications, including severe pneumonia, acute respiratory distress syndrome, multiple organ failure, and in some cases, death. In the absence of effective prevention measures, current management to control the epidemic is the enforcement of quarantine, isolation, and physical distancing. Effective vaccines against COVID-19 are urgently needed to reduce the enormous burden of mortality and morbidity associated with SARS-CoV-2 infection.

 
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