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CTRI Number  CTRI/2021/05/033752 [Registered on: 24/05/2021] Trial Registered Prospectively
Last Modified On: 18/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Other 
Public Title of Study   COVAXIN® in paediatric study  
Scientific Title of Study   A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers ages ≤18 to ≥ 2 Years 
Trial Acronym  COVAXIN 
Secondary IDs if Any  
Secondary ID  Identifier 
BBIL/BBV152/2021 version 2.0 dated 17.04.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Krishna Mohan 
Designation  Whole-Time Director 
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Limited Genome valley Shameerpet Hyderabad

Hyderabad
TELANGANA
500 078
India 
Phone  914023480567   
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Krishna Mohan 
Designation  Whole-Time Director 
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Limited Genome valley Shameerpet Hyderabad
Bharat Biotech International Limited Genome valley Shameerpet Hyderabad

TELANGANA
500 078
India 
Phone  914023480567   
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr V Krishna Mohan 
Designation  Whole-Time Director 
Affiliation  Bharat Biotech International Limited 
Address  Bharat Biotech International Limited Genome valley Shameerpet Hyderabad

Hyderabad
TELANGANA
500 078
India 
Phone  914023480567   
Fax  914023480560   
Email  kmohan@bharatbiotech.com  
 
Source of Monetary or Material Support  
Bharat Biotech International Limited, Genome valley, Shameerpet, Hyderabad 
 
Primary Sponsor  
Name  Bharat Biotech International Limited 
Address  Genome valley, Shameerpet, Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Bharat Biotech International Limited  Genome valley Shameerpet Hyderabad 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chnadramani SIngh  All India Institute of Medical Sciences Patna  Room No 105 Type 4 Block 2 Department of Paediatrics Aurangabad Road Phulwari Sharif
Patna
BIHAR 		 9931733280

cmaiims57@gmail.com 
Dr Sanjay Kumar Rai  All India Institute of Medical Scienecs Delhi  Department of center for community medicine Room no 29 Old OT block, AIIMS News Delhi
New Delhi
DELHI 		 9868397358

drsanjay.aiims@gmail.com 
Dr Prashanth   Cheluvambha Hospital Mysore Medical College and Research Institution  Department of Paediatrics Ground Floor, Room no 101, Irwin Road, Mysore
Mysore
KARNATAKA 		 9606352062

drsp2013@rediffmail.com 
Dr Vasant Khalatkar  Meditrina Institute of Medical Sciences  2nd floor Department of paediatrics Meditrina Institute of Medical Sciences 278 Central Bazar road Ramdapeth Nagpur 440010
Nagpur
MAHARASHTRA 		 9823044438
7122740600
vasant.khalatkar@gmail.com 
Dr Virendra Nath Tripathy  Prakhar Hopsital Pvt Ltd  3rd Floor, Clinical Research Department, Room No 301, Arya Nagar, Kanpur
Kanpur Nagar
UTTAR PRADESH 		 9415050777

dr.vntripathicr@gmail.com 
Dr Mirza Nizam Baig  Pranam Hospitals Hyderabad  3rd floor, Clinical Research Department, Room no: 306, Madinaguda, Hyderabad
Hyderabad
TELANGANA 		 9949389002

drmnb007@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committe, Prakhar Hospital  Approved 
Institute Ethics Committee All India Institute of Medical Sciences, New Delhi  Approved 
Institutional Ethics Committe, All India Institute of Medical Sciences, Patna  Approved 
Institutional Ethics Committe, Mysore Medical College, Mysore  Approved 
Institutional Ethics Committe, Pranaam Hospitals  Approved 
Meditrina Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BBV152  0.5 ml administered intramuscular at day 0 and day 28  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children (verbal/oral assent for the children of age between 7-12 years, and written assent for the children of age between >12 to 18 years), and Audio video consent for all participants.
2. Participants of either gender of age between ≥2 to ≤18years (Participant should be ≤18 years at the time of Screening of the study).
3. Good general health as determined by the discretion of investigator.
4. Expressed interest and availability to fulfill the study requirements.
5. Agrees not to participate in another clinical trial at any time during the study period.
6. Agrees to remain in the study area for the entire duration of the study.
7. Willing to allow storage and future use of biological samples for future research
 
 
ExclusionCriteria 
Details  1. History of any other COVID-19 investigational vaccination.
2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method.
3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine.
4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period.
5. Receipt of any licensed vaccine within four weeks before enrolment in this study.
6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past.
7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study.
8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months.
9. Long-term use (>2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed).
10. Any history of hereditary angioedema or idiopathic angioedema.
11. Any history of anaphylaxis in relation to vaccination.
12. History of congenital diseases.
13. Any history of albumin-intolerance.
14. History of any cancer.
15. History of psychiatric severe conditions likely to affect participation in the study.
16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
17. Any other serious chronic illness requiring hospital specialist supervision.
18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma.
19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness.
20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration.
21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
Re-Vaccination Exclusion Criteria
22. Anaphylactic reaction following administration of the investigational vaccine.
23. Virologically confirmed cases of COVID-19 through nucleic acid tests
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Occurrence of immediate adverse events within two hours of vaccination
2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination.
3 Occurrence of Serious Adverse Events throughout the study duration.
4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration
5 To evaluate the GMTs and seroconversion of COVAXIN® 		 Day 28±2, 56±7, 118±7 and 208±7 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate the GMT and four-fold seroconversion rate of binding antibodies (bAb’s) IgG against spike protein (S1 and RBD) and Nucleocapsid (N) protein in all three groups from baseline to day 28, 56, 118 and 208. [Time Frame: Baseline to Day 28±2, 56±7, 118±7 and 208±7].  Day 28±2, 56±7, 118±7 and 208±7 
 
Target Sample Size   Total Sample Size="525"
Sample Size from India="525" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="525" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/05/2021 
Date of Study Completion (India) 25/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   no 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart. Participants will be recruited in age de-escalatory manner as follows:

Group I: Children of age ≤18 - >12 years (n=175).

Group II: Children of age ≤12 - >6 years (n=175).

Group III: Children of age ≤ 6 - ≥ 2 years (n=175).

Group1: A total of 175 healthy volunteers ages ≤18->12, years will be enrolled in this group and will receive two doses of COVAXIN® vaccine through intramuscular route on Day 0 and Day 28+2.

Group 2: A total of 175 healthy volunteers ages ≤12- >6, years will be enrolled in this group and will receive two doses of COVAXIN® vaccine through intramuscular route on Day 0 and Day 28+2.

Group 3: A total of 175 healthy volunteers ages ≤ 6 - > 2 years will be enrolled in this group and will receive two doses of COVAXIN® vaccine through intramuscular route on Day 0 and Day 28+2.


 
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