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
Secondary IDs if Any Modification(s)	Secondary ID  Registry  ICMR/SII-COVISHIELD Version 4.0 dated 14 Oct 2020  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name    Address    Phone     Fax     Email
Details Contact Person Scientific Query	Name  Dr Prasad Kulkarni  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 Contact Person Public Query	Name  Dr Prasad Kulkarni  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 Modification(s)	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   Contact Person  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   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   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   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   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   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   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   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   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   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   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   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   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   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   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 Modification(s)	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 serious adverse events (SAEs)  Throughout the study duration following vaccination  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
Target Sample Size	Total Sample Size="1600" Sample Size from India="1600"
Phase of Trial	Phase 2/ Phase 3
Date of First Enrollment (India)	24/08/2020
Date of First Enrollment (Global)	No Date Specified
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 Modification(s)	Nil
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.