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Clinical Trial Details (PDF Generation Date :- Mon, 04 Jan 2021 05:14:53 GMT)

CTRI Number CTRI/2020/08/027170 [Registered on: 15/08/2020] - Trial Registered Prospectively

Last Modified On 26/12/2020
Post Graduate Thesis No
Type of Trial Interventional
Type of Study Vaccine
Study Design Randomized, Parallel Group Trial
Public Title of Study Study to check the safety and immune response of a COVID-19 vaccine in healthy Indian adults.
Scientific Title of A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and
Study Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults
Secondary IDs if Any Secondary ID Identifier
ICMR/SII-COVISHIELD Version 4.0 dated 14 Protocol Number
Oct 2020
Details of Principal Details of Principal Investigator
Investigator or overall
Name
Trial Coordinator
(multi-center study) Designation
Affiliation
Address

Phone
Fax
Email
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Prasad Kulkarni
Query)
Designation Medical Director
Affiliation Serum Institute of India Private Limited
Address Serum Institute of India Private Limited, 212/2, Hadapsar, Pune –
411 028, India
Pune
MAHARASHTRA
411028
India
Phone 00912026602949
Fax 00912026993945
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Dr Prasad Kulkarni
Designation Medical Director
Affiliation Serum Institute of India Private Limited
Address Serum Institute of India Private Limited, 212/2, Hadapsar, Pune –
411 028, India
Pune
MAHARASHTRA
411028
India
Phone 00912026602949
Fax 00912026993945

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Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, INDIA
> Serum Institute of India Private Limited 212/2, Hadapsar, Pune – 411 028, India
Primary Sponsor Primary Sponsor Details
Name Serum Institute of India Private Limited
Address 212/2, Off Soli Poonawalla Road, Hadapsar, Pune – 411 028, India
Type of Sponsor Pharmaceutical industry-Indian
Details of Secondary Name Address
Sponsor
Indian Council of Medical Research ICMR V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, INDIA
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr B Devi Madhavi Andhra Medical Department of 918912712258
College, Community Medicine
Visakhapatnam Andhra Medical College drdevimadhavi@rediffm
Maharani Peta, ail.com
Visakhapatnam, Andhra
Pradesh 530002, India
Visakhapatnam
ANDHRA PRADESH
Dr Muralidhar Tambe B J Medical College B J Medical College 912026128000
and Sassoon General and Sassoon General
Hospital, Pune Hospital, Jai Prakash muralidhartambe@gmai
Narayan Road, Pune l.com
Railway Station, Pune,
Maharashtra 411001,
India
Pune
MAHARASHTRA
Dr Sanjay Lalwani Bharati Vidyapeeth Department of 912024364308
Deemed University Pediatrics Bharati
Medical College and Vidyapeeth Deemed researchpedpune@gm
Hospital, Pune University Medical ail.com
College and Hospital,
Dhankawadi, Pune-
Satara Road, Pune-
411043, Maharashtra,
India
Pune
MAHARASHTRA
Dr Sushant Meshram Government Medical Department of 917122744671
College, Nagpur Respiratory Medicine,
Government Medical [email protected]
College, Near m
Hanuman Nagar,
Nagpur, Maharashtra
440009
Nagpur
MAHARASHTRA
Dr T S Selvavinayagam Institute of Community Institute of Community 914425305000
Medicine, Madras Medicine, Madras

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Medical College, Old [email protected]

Central Jail Campus, om
Park Town, Chennai-
600 003, Tamil Nadu,
India
Chennai
TAMIL NADU
Dr Kiranjit Singh Jehangir Hospital, Pune Jehangir Clinical 912066819999
Development Center,
Jehangir Hospital [email protected]
premises, 32 Sassoon
Road, Pune 411 001,
Maharashtra, India
Pune
MAHARASHTRA
Dr Praveen Kulkarni JSS Academy of Higher Department of 918212548416
Education and Community Medicine,
Research, Mysore JSS Academy of Higher [email protected]
Education and
Research Bannimantap
Road, Sri
Shivarathreeshwara
Nagara, Bannimantap A
Layout, Bannimantap,
Mysore, Karnataka
570015, India
Mysore
KARNATAKA
Dr Ashish Bavdekar KEM Hospital Research Department of 020-66037342
Centre, Vadu Paediatrics, KEM
Hospital Research a.bavdekar@kemhrcpu
Centre Vadu Rural ne.org
Health Program, Vadu
Budruk, Taluka Shirur,
Pune - 412216,
Maharashtra, India
Pune
MAHARASHTRA
Dr B S Garg Mahatma Gandhi Department of 917152284341
Institute of Medical Community Medicine,
Sciences, Sewagram Dr Sushila Nair School [email protected]
of Public Health
Mahatma Gandhi
Institute of Medical
Sciences, Sewagram,
Wardha, Maharashtra
442102
Wardha
MAHARASHTRA
Dr Madhu Gupta Post Graduate Institute Department of 911722755223
of Medical Education & Community Medicine
Research (PGIMER) and School of Public madhugupta21@gmail.
Health, Post Graduate com
Institute of Medical
Education & Research
(PGIMER), Sector -12,
Chandigarh- 160012
Punjab, India
Chandigarh
CHANDIGARH

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Dr Krishna Pandey Rajendra Memorial Rajendra Memorial 916122245744

Research Institute of Research Institute of
Medical Sciences, Medical Sciences drkrishnapandey@yaho
Patna (Indian Council of o.com
Medical Research)
Department of Health
Research, Ministry of
Health & Family
Welfare, Govt of India,
Agamkuan,
Patna-800007, Bihar,
India
Patna
BIHAR
Dr Nithya Gogtay Seth G. S. Medical Department of Clinical 00912224133767
College and KEM Pharmacology, Seth G.
Hospital, Mumbai S. Medical College and [email protected]
KEM Hospital Acharya
Donde Marg, Parel
East, Parel, Mumbai,
Maharashtra 400012,
India
Mumbai
MAHARASHTRA
Dr Ramkrishnan Sri Ramchandra Sri Ramchandra 00914445928916
Institute of Higher Institute of Higher
Education and Education and srmcclinicalresearch@g
Research, Chennai Research, No. 1, mail.com
Ramchandra Nagar,
Porur, Chennai, Tamil
Nadu 600116
Chennai
TAMIL NADU
Dr Renuka Munshi TN Medical College & TN Medical College & 02223027000
BYL Nair Hospital, BYL Nair Hospital, 5th
Mumbai floor, Department of renuka.munshi@gmail.
Clinical Pharmacology, com
TN Medical College &
BYL Nair Hospital, Dr.
AL Nair Road, Mumbai
Central, Mumbai,
Maharashtra 400008
Mumbai
MAHARASHTRA
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Mahatma Gandhi Approved 27/08/2020 No
Institute of Medical
Sciences, Institutional
Ethics Commitee,
Sewagram
Ethics Committee Approved 14/08/2020 No
Jehangir Clinical
Development Center
Pvt.Ltd, Pune
Ethics Committee Approved 18/08/2020 No
Rajendra Memorial
Research Institute of
Medical Sciences,

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Patna
IEC King George Approved 17/08/2020 No
Hospital,
Visakhapatnam
Institutional Ethics Approved 13/08/2020 No
Committee -
TNGMSSH, Chennai
Institutional Ethics Approved 16/08/2020 No
Committee of B. J.
Government Medical
College and Sassoon
General Hospital, Pune
Institutional Ethics Approved 05/09/2020 No
Committee Seth GS
Medical College and
KEM Hospital, Mumbai.
Institutional Ethics Approved 26/08/2020 No
Committee Sri
Ramachandra Institute
of Higher Education
and Research, Chennai
Institutional Ethics Approved 14/08/2020 No
Committee, BVDU,
Pune
Institutional Ethics Approved 23/09/2020 No
Committee,
Government Medical
College, Nagpur
Institutional Ethics Approved 14/08/2020 No
Committee, JSS
Medical College,
Mysore
Institutional Ethics Approved 20/08/2020 No
Committee, PGIMER,
Chandigarh
Institutional Ethics Approved 28/08/2020 No
Committee, T N
Medical College & BYL
Nair Hospital, Mumbai
KEM Hospital Research Approved 13/08/2020 No
Centre Ethics
Committee, Pune
Regulatory Clearance Status Date
Status from DCGI
Approved/Obtained 16/10/2020
Health Condition / Health Type Condition
Problems Studied
Healthy Human Volunteers Prevention of COVID-19 infection
Intervention / Type Name Details
Comparator Agent
Intervention Covishield (SII-ChAdOx1 Covishield will be administered
nCoV-19) as 2 dose schedule on Days 1
and 29 as 0.5 ml dose
intramuscularly.
Comparator Agent Oxford/AZ-ChAdOx1 nCoV-19 Oxford/AZ-ChAdOx1 nCoV-19
vaccine vaccine will be administered as
2 dose schedule on Days 1 and
29 as 0.5 ml dose

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intramuscularly.
Comparator Agent Placebo Placebo will be administered as
2 dose schedule on Days 1 and
29 as 0.5 ml dose
intramuscularly.
Inclusion Criteria Inclusion Criteria
Age From 18.00 Year(s)
Age To 99.00 Year(s)
Gender Both
Details 1. Healthy adults aged more than or equal to 18 years of either sex.
2. Written informed consent by participants.
3. The participant is resident of the study area and is willing to
comply with study protocol requirements.
4. Healthy, as determined by medical history and physical
examination.
5. Female participants of childbearing potential must have a negative
urine pregnancy test within 24 hours prior to study vaccine
administration.
Exclusion Criteria Exclusion Criteria
Details 1. Acute illness with or without fever at the time of study vaccine
administration
2. History of laboratory confirmed COVID-19 disease in household
contact or close workplace contact
3. IgG seropositivity to SARS-CoV-2
4. History or currently positive for SARS-CoV-2 by RT-PCR
5. History of severe allergic reactions after previous vaccinations or
hypersensitivity to any component of study vaccines
6. Any confirmed or suspected condition with impaired/altered
function of immune system
Method of Generating Computer generated randomization
Random Sequence
Method of Centralized
Concealment
Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome Outcome Timepoints
1. Occurrence of causally related SAEs 1. Throughout the study duration following
throughout the study duration following vaccination
vaccination 2. 28 days after the second
2. Ratio of GMTs vaccination
of anti-S IgG antibodies
Secondary Outcome Outcome Timepoints
Occurrence of solicited local and/or systemic 7 days following each vaccination
adverse events (AEs)
Occurrence of unsolicited adverse events 28 days following each vaccination
Occurrence of serious adverse events (SAEs) Throughout the study duration following
vaccination
Target Sample Size Total Sample Size=1600
Sample Size from India=1600
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 2/ Phase 3
Date of First 24/08/2020
Enrollment (India)
Date of First No Date Specified

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Enrollment (Global)
Estimated Duration of Years=0
Trial Months=7
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Closed to Recruitment of Participants
Trial (India)
Publication Details Nil
Brief Summary This is a Phase 2/3, observer-blind, randomised, controlled study in healthy adults in India, for
comparison of the safety of COVISHIELD with Oxford/AZ-ChAdOx1 nCoV-19 and Placebo, and
immunogenicity with Oxford/AZ-ChAdOx1 nCoV-19 in prevention of SARS CoV-2 infection. A total
of 1600 eligible participants of more than or equal to 18 years of age will be enrolled the study. Of
these 400 participants will be part of immunogenicity cohort and will be randomly assigned in a 3:1
ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining
1200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either
COVISHIELD or Placebo, respectively.

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