CTRI/2021/01/030416 [Registered on: 12/01/2021] Trial Registered Prospectively
Last Modified On:
30/08/2022
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.
DIVINE Multispecialty Hospital and Cancer Centre, Wazirabad, Delhi
New Delhi
9212410444
devinehospiresearch@gmail.com
Dr Swapnav Borthakur
Downtown Hospita
Dispur, G S Road, Guwahati-781006 Kamrup
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
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
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
Athibabbe Road, 30th Main Road,
Near BDA Shopping Complex, Banashankari Stage II, Banashankari, Bengaluru, Karnataka – 560070 Bangalore
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
8312444444
rajendranerli@yahoo.in
Dr Sreedevi A
Kurnool Medical College and Governement General Hospital
"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 "
"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 "
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.
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
(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.
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.
