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CTRI Number  CTRI/2021/02/031554 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 06/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study
Modification(s)  
The study to check the safety and immune response of (Covid-19 vaccine) COVOVAX in adults (more than 18 years of age) and pediatric population (more than 2 years and less than 17 years of age) in India. 
Scientific Title of Study
Modification(s)  
A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults aged ≥18 years and children aged 2 to 17 years 
Trial Acronym  ICMR/SII-COVOVAX 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ICMR/SII-COVOVAX Version: 9.0 Dated 26 July 2021  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  Executive 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  0912026993945  
Email  drpsk@seruminstitute.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasad Kulkarni 
Designation  Executive 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  0912026993945  
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi 
Serum Institute of India Private Limited, Pune 
 
Primary Sponsor  
Name  Serum Institute of India Private Limited Pune 
Address  Serum Institute of India Private Limited 212/2, Hadapsar, Pune – 411 028, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Indian Council of Medical Research New Delhi  Indian Council of Medical Research, 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 = 23  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Hadda  All India Institute of Medical Sciences (AIIMS), New Delhi  Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences (AIIMS),Ansari Nagar, New Delhi – 110029 India
New Delhi
DELHI 
01126588500

vijayhadda@yahoo.com 
Dr Hira Lal Bhalla  All India Institute of Medical Sciences, Gorakhpur  Department of Pharmacology, All India Institute of Medical Sciences, Department of Pharmacology, Gorakhpur, Uttar Pradesh - 273008
Gorakhpur
UTTAR PRADESH 
05512205572

hirabhalla@gmail.com 
Dr Dipu Thareparambil S  Amrita Institute of Medical Sciences, Kochi  Department of General Medicine and Division of Infectious diseases, T2F3, Amrita Institute of Medical Sciences, Department of General Medicine, Ponekkara, Kochi, Kerala-682041, India
Kollam
KERALA 
04842852250

diputsmck@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 
00912024364308

researchpedpune@gmail.com 
Dr Clarence Samuel  Christian Medical College and Hospital, Ludhiana  Department of Community Medicine, Christian Medical College & Hospital, Brown Rd, Ludhiana, Punjab 141008, India
Ludhiana
PUNJAB 
01612115389

clarencejs@yahoo.com 
Dr Abhay Gaidhane  Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha  Acharya Vinoba Bhave Rural Hospital, First Floor, Room no 221 - School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Sawangi (M), Wardha, Maharashtra- 442004, India
Wardha
MAHARASHTRA 
07152287742

abhaygaidhane@gmail.com 
Dr Varsha Bhatt  Dr. D. Y. Patil Medical college, Hospital And Research Centre, Pune  Department Of Medicine, Dr. D. Y. Patil Medical college, Hospital And Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra-411018, India
Pune
MAHARASHTRA 
02027805000

drvrbhatt@gmail.com 
Dr Sushant Meshram  Government Medical College and Hospital, Nagpur  Department of Pulmonary Medicine, Super Specialty Hospital, GMC Nagpur, Government Medical College and Hospital, Tukdoji Square, Nagpur, Maharashtra – 440009 India
Nagpur
MAHARASHTRA 
07122743588

drsushant.in@gmail.com 
Dr Sunil Kohli  Hamdard Institute of Medical Sciences and Research, New Delhi  Department of Medicine, Room No 110, Block B, Hamdard Institute of Medical Sciences and Research with Centre for health Research and Development (CHRD),Society for Apllied Studies (SAS),Guru Ravidas Marg, Hamdard Nagar, New Delhi-110062, India
New Delhi
DELHI 
01126059688

drskohli.himsr@gmail.com 
Dr Rakhi Ludam  Institute of Medical Sciences & SUM Hospital, Bhubaneshwar  Department of Pulmonary Medicine, Institute of Medical Sciences and SUM Hospital, Kalinga Nagar, Bhubaneswar, Khordha, Orissa 751003
Khordha
ORISSA 
06742386281

rakhiludam@soa.ac.in 
Dr Tamilarasu Kadhiravan  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry  Department of Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Puducherry- 605006, India
Pondicherry
PONDICHERRY 
04132272380

kadhiravan@gmail.com 
Dr Praveen Kulkarni  JSS Academy of Higher Education and Research, Mysore  Department of Community Medicine, JSS Medical College, JSS Hospital, Mahatma Gandhi Road, Mysuru – 570004 Karnataka, India
Mysore
KARNATAKA 
08212335555

prakulfi@gmail.com 
Dr Sonali Kar  Kalinga Institute of Medical Sciences, Bhubaneswar  Department of Community Medicine, Kalinga Institute of Medical Sciences, Kushabhadra Campus , KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024, India
Bargarh
ORISSA 
06742304400

sonsam72@yahoo.co.uk 
Dr Ashish Bavdekar  KEM Hospital Research Centre Vadu  Clinical Research, KEM Hospital Research Centre Vadu Rural Health Program, Vadu Budruk, Taluka Shirur, Pune, Maharashtra- 412216, India
Pune
MAHARASHTRA 
02066037342

a.bavdekar@kemhrcpune.org 
Dr Ashwath Narayana  KIMS Hospital and Research centre, Bangalore  Preventive Medicine Unit, Department of Community Medicine, Room No-12, Ground Floor, B-Block, KIMS Hospital and Research centre, Krishna Rajendra Rd, Vishweshwarapura, Bengaluru, Karnataka 560004, India
Bangalore
KARNATAKA 
08026601162

dhashwathnarayana@gmail.com 
Dr Madhav Prabhu  KLES Dr. Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belgavi   Department of Medicine, KLES Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belgavi Karnataka 590010, India
Belgaum
KARNATAKA 
08312474414

maddy2380@gmail.com 
Dr Abhishek Raut  Mahatma Gandhi Institute of Medical Sciences, Sewagram  Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram - 442102, Wardha, Maharashtra, India
Wardha
MAHARASHTRA 
07152284341

abhishekraut@mgims.ac.in 
Dr Sidram Raut  Noble Hospital, Pune  Clinical Research Department, Noble Hospital, 153, Road, Magarpatta, Hadapsar, Pune, Maharashtra-411013, India
Pune
MAHARASHTRA 
02066285568

skrcorporate@yahoo.co.uk 
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 
0911722755223

madhugupta21@gmail.com 
Dr Govind Kulkarni  Sahyadri Super speciality Hospital, Pune  Clinical Research - Department of Medicine, Sahyadri Super speciality Hospital, Survey no.185A, Shastri nagar, Yerwada, Nagar road, Pune, Maharashtra- 411004, India
Pune
MAHARASHTRA 
02067271111

drgdk2001@yahoo.co.uk 
Dr Santanu Tripathi  School of Tropical Medicine, Kolkata  Department of Clinical and Experimental Pharmacology, School of Tropical Medicine 108, Chittaranjan Ave, Kolkata, West Bengal 700073, India
Kolkata
WEST BENGAL 
03322123695

tripathi.santanu@gmail.com 
Dr Nithya Gogtay  Seth G S Medical College and KEM Hospital, Parel, Mumbai  Department of Clinical Pharmacology 1st Floor, M S Building, Seth G S Medical College and KEM Hospital, Parel, Mumbai 400012, India
Mumbai
MAHARASHTRA 
02224133767

njgogtay@hotmail.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 
002223027000

renuka.munshi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 23  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, School of Tropical Medicine, Kolkata  Approved 
Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pune  Approved 
Institutional Ethics Committee Amrita Institute of Medical Sciences AIMS-Ponekkara Kochi  Approved 
Institutional Ethics committee Bharati Vidyapeeth Deemed University, Pune  Submittted/Under Review 
Institutional Ethics Committee Christian Medical College & Hospital Ludhiana  Approved 
Institutional Ethics Committee Government Medical College and Hospital Nagpur  Approved 
Institutional Ethics Committee Intervention Studies, JIPMER, Puducherry  Approved 
Institutional Ethics Committee of DMIMS, Datta Meghe Institute of Medical Sciences, Sawangi (Meghe) Wardha  Approved 
Institutional Ethics Committee Topiwala National Medical College and B.Y.L. Nair Charitable Hospital  Submittted/Under Review 
Institutional Ethics Committee, Mahatma Gandhi Institute of Medical Sciences, Sewagram  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi  Approved 
Institutional Ethics Committee, IMS & SUM Hospital Bhubaneswar  Approved 
Institutional Ethics Committee, JSS Medical College, Mysore  Approved 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, Bhubneswar   Approved 
Institutional Ethics Committee, KLE University, Belgaum  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research-(PGIMER), Chandigarh  Submittted/Under Review 
Institutional Ethics Committee-1 Seth GS Medical College and KEM Hospital, Mumbai  Submittted/Under Review 
Institutional Human Ethics Committee All India Institute Of Medical Sciences, Gorakhpur  Approved 
Jamia Hamdard Institutional Ethics Committee, New Delhi  Approved 
KEM Hospital Research Centre Ethics Committee, Pune  Approved 
KIMS Institutional Ethics Committee, Bangalore  Approved 
Noble Hospital Institutional Ethics Committee, Pune  Approved 
Sahyadri Hospitals Ltd. 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  COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant]  Adult cohort: Phase 2 part: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] Manufacturer: DS manufactured by Novavax and DP (fill finish) by SIIPL. Phase 3 part: COVOVAX; Manufacturer: Serum Institute of India Pvt. Ltd. Pediatric cohort: Test vaccine: COVOVAX; DS and DP manufactured by SIIPL 
Comparator Agent  Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant  Adult Cohort: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant. DS and DP manufactured by Novavax 
Comparator Agent  Placebo  Adult Cohort (Phase 2 part) and Pediatric Cohort: Placebo: 0.9% Normal saline (Sodium chloride) for injection. 
 
Inclusion Criteria
Modification(s)  
Age From  2.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult Cohort:
1. 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. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit
6. Female participants of childbearing potential must have a negative
urine pregnancy test within 24 hours prior to study vaccine

Pediatric Cohort:
1. Children aged ≥ 2 to 17 years of either sex
2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study
3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator.
4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children
5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures.
6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration 
 
ExclusionCriteria 
Details  Adult Cohort:
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease.
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
4. Prior receipt of an investigational or licensed vaccine likely to
impact interpretation of the trial data
5. Current or planned participation in prophylactic drug trials for the
duration of the study
Pediatric Cohort
1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration
2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease
3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines  
 
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 
Occurrence of causally related serious
adverse events (SAEs) throughout the study duration following vaccination

Immunogenicity Outcomes:
a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2

Safety Outcomes:

a. Occurrence of solicited local and systemic AEs  
Throughout the study follow up period

14 days after second vaccination (35 days post first dose vaccination)

For 7 days following each dose

35 days post first dose vaccination

Throughout the study period following vaccination 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Occurrence of solicited local and systemic adverse events (AEs)  7 days following each dose 
Occurrence of unsolicited adverse
events including medically attended
adverse events (MAAEs) for  
35 days post first dose vaccination 
Occurrence of SAEs, related
MAAEs, and adverse events of
special interest (AESI) which encompasses potential immunemediated medical conditions (PIMMCs) and AESIs relevant to COVID-19 
Throughout the study
duration following vaccination 
GMEUs of anti-S IgG antibodies  Baseline, Day 21, Day 35 and Day 179 post first dose vaccination 
Seroconversion for anti-S IgG  Day 21, Day 35 and Day 179 post first dose vaccination 
Pediatric cohort:
Immunogenicity Outcomes:
a. GMEUs of anti-S IgG antibodies and Seroconversion for anti-S IgG 
At baseline, 21, 35- and 179-days post first dose vaccination.  
b. GMTs of NAb against SARS-CoV-2
 
At baseline and 35 days post first dose vaccination. 
 
Target Sample Size
Modification(s)  
Total Sample Size="2520"
Sample Size from India="2520" 
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 Enrollment (India)   26/02/2021 
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="0"
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
Modification(s)  

This is a Phase 2/3, observer-blinded, randomized, controlled study in adults ≥ 18 years and children of ≥ 2 to 17 years of age in India.

 Adult Cohort:

A total of 1600 eligible participants of ≥ 18 years of age will be enrolled in this study. Of these, 460 participants will be part of reactogenicity and immunogenicity cohort. The remaining 1140 participants will be part of safety cohort.

All eligible participants (n=1600) will receive two doses of 0.5 mL each of either COVOVAX or Control vaccine (Novavax- SARS-CoV-2 rS with Matrix-M1™ Adjuvant) or Placebo on Day 1 and Day 22 as per randomization. Post vaccination site visits are planned on Day 22, Day 36, Day 85 and Day 180.

The study will be conducted in two parts as below:

Phase 2 part: Initial 200 participants have been enrolled in the Safety cohort with 3:1 allocation to COVOVAX (n=150) or Placebo (n=50).

Phase 3 part: Enrolment of remaining 1400 participants (940 from the Safety cohort and 460 from the reactogenicity and immunogenicity cohort) will be done.

Pediatric cohort:

The study objective in this cohort is to evaluate the safety of COVOVAX in comparison with Placebo; and immunogenicity of COVOVAX in children ≥ 12 to 17 years of age and ≥ 2 to 11 years of age in comparison with adult participants (adult participants in the reactogenicity and immunogenicity cohort from COVOVAX group), separately.

A total of 920 eligible children of ≥ 2 years of age will be enrolled in this study. Of these, 460 participants will be of ≥ 12 to 17 years of age and 460 participants will be of ≥ 2 to 11 years of age.

All eligible participants (n=920) will be randomized in 3:1 ratio to receive two doses of 0.5 mL each of either COVOVAX or Placebo, respectively, on Day 1 and Day 22.

 
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