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CTRI Number  CTRI/2022/04/042017 [Registered on: 21/04/2022] Trial Registered Prospectively
Last Modified On: 30/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to check the effect of Covovax vaccine when administered as booster dose in adults in India who have already received two doses of COVID-19 vaccines 
Scientific Title of Study   A phase 3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of a booster dose of COVOVAX in Indian adults who have received primary vaccination against COVID-19 
Trial Acronym  COVOVAX-Booster 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
COVOVAX-Booster Version No. 4.0 Dated 21 April 2022  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 – 411028, India

Pune
MAHARASHTRA
411028
India 
Phone  00912071946820  
Fax  00912026993945  
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 – 411028, India

Pune
MAHARASHTRA
411028
India 
Phone  00912071946820  
Fax  00912026993945  
Email  drpsk@seruminstitute.com  
 
Source of Monetary or Material Support  
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 – 411028, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
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 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
Satara
MAHARASHTRA 
00912024364308

researchpedpune@gmail.com 
Dr Srikanth Tripathy  Dr. D. Y. Patil Medical college, Hospital And Research Centre, Pune  Medical Research Department, Dr. D. Y. Patil Medical College, Hospital And Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra-411018, India
Pune
MAHARASHTRA 
020-27805100

srikanthtripathy@gmail.com 
Dr Sunil Kohli  Hamdard Institute of Medical Sciences and Research, New Delhi  Department of Medicine, Room No110, 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
New Delhi
DELHI 
01126059688

drskohli.himsr@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
Khordha
ORISSA 
0674-2725708

sonsam72@yahoo.co.uk 
Dr Aditi Apte  KEM Hospital Research Centre Manchar  KEM Hospital Research Centre-Community Health Research Unit Third Floor, Shrivinayak Hospital, Mulewadi Road P.O Manchar, Taluka Ambegaon District- Pune. 410503, Maharashtra, India
Pune
MAHARASHTRA 
020-26065603

dr.aditiapte@gmail.com 
Dr S K Raut  Noble Hospitals Pvt. Ltd., Pune  Noble Hospital Pvt. Ltd., 153/A, Magarpatta City Road, Hadapsar, Pune 411013, Maharashtra, India
Pune
MAHARASHTRA 
02066285120

skraut01@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pune  Submittted/Under Review 
Institutional Ethics Committee Bharati Vidyapeeth Deemed University, Pune  Submittted/Under Review 
Institutional Ethics Committee, HIMSR and Associated HAH Centenary Hospital, New Delhi   Submittted/Under Review 
Institutional Ethics Committee, JSS Medical College, Mysore  Submittted/Under Review 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, Bhubneswar  Approved 
Institutional Human Ethics Committee All India Institute Of Medical Sciences, Gorakhpur  Submittted/Under Review 
KEM Hospital and Research center ethics committee  Approved 
Noble Hospital Institutional Ethics Committee, Pune  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of COVID-19 infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COVAXIN  COVAXIN (Whole Virion Inactivated Coronavirus (SARS-CoV-2) Vaccine) is a white to off white, opalescent suspension free from extraneous particles containing 6 μg of Whole Virion, Inactivated (SARS-CoV-2) Antigen (strain NIV-2020-770). Manufacturer- Bharat Biotech International Limited Dose: 0.5 mL Frequency: Single dose Route of administration: Intramuscular 
Comparator Agent  COVISHIELD  COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)) One dose (0.5 ml) contains: ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) 5 × 1010 virus particles (vp) Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells. Manufacturer- Serum Institute of India Pvt. Ltd. Dose: 0.5 mL Frequency: Single dose Route of administration: Intramuscular 
Intervention  COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant]  Single dose of 0.5 mL contains 5 μg antigen and 50 μg Matrix-M1 adjuvant. Dose: 0.5 mL Frequency: Single dose Route of administration: Intramuscular 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults aged more than or equal to 18 years of either sex
2. Written informed consent by participants
3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago
4. 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 at the time of screening
2. History of laboratory confirmed COVID-19
3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19
4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw
5. Suspected or known current alcohol or drug dependence
6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period
7. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
8. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination
9. Prior receipt of a booster dose of COVID-19 vaccine
10. Pregnant or breast-feeding
11. Acute or chronic, clinically significant systemic disorders
12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol 
 
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 
Anti-S IgG and Neutralizing antibodies  28 days after vaccination 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccination  7 days post-vaccination 
Occurrence of unsolicited AEs for 28 days post-vaccination  28 days post-vaccination 
Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccination  180 Days Post Vaccination 
Anti-S IgG and Neutralizing antibodies  at Day 91 and Day 181 
 
Target Sample Size   Total Sample Size="372"
Sample Size from India="372" 
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 3 
Date of First Enrollment (India)   25/04/2022 
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)  Closed to Recruitment of Participants 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Phase 3, observer-blinded, randomised, active controlled study in adults of more than or equal to 18 years of age in India who have already received primary vaccination against COVID-19 at least 6 months ago (6 months or 180 days from the second dose), to evaluate the immunogenicity and safety of the COVOVAX booster dose in comparison with the control vaccine.

A total of 372 eligible participants of ≥ 18 years of age who have completed primary 2 dose schedule of COVID-19 vaccination at least 6 months ago will be enrolled in this study in 2 cohorts of 186 participants each with 1:1 allocation to COVOVAX or control vaccine. Two cohorts of 186 participants each will be as below:

1. COVISHIELD Prime cohort: Primary vaccination with two doses of COVISHIELD

2. COVAXIN Prime cohort: Primary vaccination with two doses of COVAXIN

A total of 372 eligible participants (186 participants from each of 2 cohorts) will be randomized as mentioned above to receive study vaccines. The study vaccines will be injected intramuscularly in the deltoid as a single dose of 0.5 mL on Day 1. The participants will be observed closely for at least 30 minutes following vaccination. 

 
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