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CTRI Number  CTRI/2020/08/027170 [Registered on: 15/08/2020] Trial Registered Prospectively
Last Modified On: 12/06/2021
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 Study   A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults 
Trial Acronym  ICMR/SII-COVISHIELD 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ICMR/SII-COVISHIELD Version 4.0 dated 14 Oct 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific 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  
Email  drpsk@seruminstitute.com  
 
Details of Contact 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  
Email  drpsk@seruminstitute.com  
 
Source of Monetary or 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  
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 Sponsor  
Name  Address 
Indian Council of Medical Research ICMR  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, INDIA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B Devi Madhavi  Andhra Medical College, Visakhapatnam  Department of Community Medicine Andhra Medical College Maharani Peta, Visakhapatnam, Andhra Pradesh 530002, India
Visakhapatnam
ANDHRA PRADESH 		 918912712258

drdevimadhavi@rediffmail.com 
Dr Muralidhar Tambe  B J Medical College and Sassoon General Hospital, Pune  B J Medical College and Sassoon General Hospital, Jai Prakash Narayan Road, Pune Railway Station, Pune, Maharashtra 411001, India
Pune
MAHARASHTRA 		 912026128000

muralidhartambe@gmail.com 
Dr Sanjay Lalwani  Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune  Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital, Dhankawadi, Pune- Satara Road, Pune- 411043, Maharashtra, India
Pune
MAHARASHTRA 		 912024364308

researchpedpune@gmail.com 
Dr Sushant Meshram  Government Medical College, Nagpur  Department of Respiratory Medicine, Government Medical College, Near Hanuman Nagar, Nagpur, Maharashtra 440009
Nagpur
MAHARASHTRA 		 917122744671

drsushant.in@gmail.com 
Dr T S Selvavinayagam  Institute of Community Medicine, Madras  Institute of Community Medicine, Madras Medical College, Old Central Jail Campus, Park Town, Chennai- 600 003, Tamil Nadu, India
Chennai
TAMIL NADU 		 914425305000

drsvinayagam@gmail.com 
Dr Kiranjit Singh  Jehangir Hospital, Pune  Jehangir Clinical Development Center, Jehangir Hospital premises, 32 Sassoon Road, Pune 411 001, Maharashtra, India
Pune
MAHARASHTRA 		 912066819999

startup@jcdc.co.in 
Dr Praveen Kulkarni  JSS Academy of Higher Education and Research, Mysore  Department of Community Medicine, JSS Academy of Higher Education and Research Bannimantap Road, Sri Shivarathreeshwara Nagara, Bannimantap A Layout, Bannimantap, Mysore, Karnataka 570015, India
Mysore
KARNATAKA 		 918212548416

prakulfi@gmail.com 
Dr Ashish Bavdekar  KEM Hospital Research Centre, Vadu  Department of Paediatrics, KEM Hospital Research Centre Vadu Rural Health Program, Vadu Budruk, Taluka Shirur, Pune - 412216, Maharashtra, India
Pune
MAHARASHTRA 		 020-66037342

a.bavdekar@kemhrcpune.org 
Dr B S Garg  Mahatma Gandhi Institute of Medical Sciences, Sewagram  Department of Community Medicine, Dr Sushila Nair School of Public Health Mahatma Gandhi Institute of Medical Sciences, Sewagram, Wardha, Maharashtra 442102
Wardha
MAHARASHTRA 		 917152284341

bsgarg@mgims.ac.in 
Dr Madhu Gupta  Post Graduate Institute of Medical Education & Research (PGIMER)  Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education & Research (PGIMER), Sector -12, Chandigarh- 160012 Punjab, India
Chandigarh
CHANDIGARH 		 911722755223

madhugupta21@gmail.com 
Dr Krishna Pandey  Rajendra Memorial Research Institute of Medical Sciences, Patna  Rajendra Memorial Research Institute of Medical Sciences (Indian Council of Medical Research) Department of Health Research, Ministry of Health & Family Welfare, Govt of India, Agamkuan, Patna-800007, Bihar, India
Patna
BIHAR 		 916122245744

drkrishnapandey@yahoo.com 
Dr Nithya Gogtay  Seth G. S. Medical College and KEM Hospital, Mumbai  Department of Clinical Pharmacology, Seth G. S. Medical College and KEM Hospital Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012, India
Mumbai
MAHARASHTRA 		 00912224133767

njgogtay@hotmail.com 
Dr Ramkrishnan  Sri Ramchandra Institute of Higher Education and Research, Chennai  Sri Ramchandra Institute of Higher Education and Research, No. 1, Ramchandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU 		 00914445928916

srmcclinicalresearch@gmail.com 
Dr Renuka Munshi  TN Medical College & BYL Nair Hospital, Mumbai  TN Medical College & BYL Nair Hospital, 5th floor, Department of Clinical Pharmacology, TN Medical College & BYL Nair Hospital, Dr. AL Nair Road, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA 		 02223027000

renuka.munshi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Mahatma Gandhi Institute of Medical Sciences, Institutional Ethics Commitee, Sewagram  Approved 
Ethics Committee Jehangir Clinical Development Center Pvt.Ltd, Pune  Approved 
Ethics Committee Rajendra Memorial Research Institute of Medical Sciences, Patna  Approved 
IEC King George Hospital, Visakhapatnam  Approved 
Institutional Ethics Committee - TNGMSSH, Chennai  Approved 
Institutional Ethics Committee of B. J. Government Medical College and Sassoon General Hospital, Pune  Approved 
Institutional Ethics Committee Seth GS Medical College and KEM Hospital, Mumbai.  Approved 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research, Chennai  Approved 
Institutional Ethics Committee, BVDU, Pune  Approved 
Institutional Ethics Committee, Government Medical College, Nagpur  Approved 
Institutional Ethics Committee, JSS Medical College, Mysore  Approved 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee, T N Medical College & BYL Nair Hospital, Mumbai  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of COVID-19 infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Covishield (SII-ChAdOx1 nCoV-19)  Covishield will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly. 
Comparator Agent  Oxford/AZ-ChAdOx1 nCoV-19 vaccine  Oxford/AZ-ChAdOx1 nCoV-19 vaccine will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose 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  
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. 
 
ExclusionCriteria 
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 Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Occurrence of causally related SAEs throughout the study duration following vaccination
2. Ratio of GMTs
of anti-S IgG antibodies 		 1. Throughout the study duration following vaccination
2. 28 days after the second
vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of solicited local and/or systemic adverse events (AEs)  7 days following each vaccination 
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)= "0"
Final Enrollment numbers achieved (India)="1600" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/08/2020 
Date of Study Completion (India) 02/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 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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