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CTRI Number  CTRI/2022/04/041880 [Registered on: 18/04/2022] Trial Registered Prospectively
Last Modified On: 05/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Safety, Tolerability and Immunogenicity of the candidate GEMCOVAC-19 (COVID-19 vaccine) in healthy pediatric subjects of 5 to less than 18 years  
Scientific Title of Study   A Prospective, Multicentre, Randomized, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of the candidate GEMCOVAC-19 (COVID-19 vaccine) in healthy pediatric subjects of 5 to less than 18 years  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GBL/GEMCOVAC-19/2022/01 Version 3.0 Dated 10 Feb 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 Amit Saraf  
Designation  Assistant General Manager (AGM) 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Clinical Research Department , Gennova Vaccine Formulation Centre and Research, Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi.

Pune
MAHARASHTRA
411057
India 
Phone  02035250000  
Fax    
Email  amit.saraf@gennova.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Saraf  
Designation  Assistant General Manager (AGM) 
Affiliation  Gennova Biopharmaceuticals Limited 
Address  Clinical Research Department , Gennova Vaccine Formulation Centre and Research, Laboratory, BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi.

Pune
MAHARASHTRA
411057
India 
Phone  02035250000  
Fax    
Email  amit.saraf@gennova.co.in  
 
Source of Monetary or Material Support  
Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057  
 
Primary Sponsor  
Name  Gennova Biopharmaceuticals Limited  
Address  Gennova Biopharmaceuticals Limited, Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC, Hinjawadi, Pune- 411057, Maharashtra  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Atul Jindal  All India Institute of Medical Sciences  All India Institute of Medical Sciences, Pediatric OPD, First Floor, B Block, Gate No. 04, G.E. Road, Tatibandh, 492099
Raipur
CHHATTISGARH 
8224014667

dratuljindal@gmail.com 
Dr Jagdish Prasad Goyal  All India Institute of Medical Sciences  All India Institute of Medical Sciences, 1st Floor, Room Mo. 103, Aayush Building, Basni Industrial Area, MIA 2nd Phase, Basni, 342005,
Jodhpur
RAJASTHAN 
8475000270

jpgoyal@rediffmail.com 
Dr Kiritkumar Jesabhai Sisodiya  BAPS Pramukh Swami Hospital  BAPS Pramukh Swami Hospital, Clinical Research Department, Ground Floor, Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan,395009
Surat
GUJARAT 
9879194433

kiritsisodiya@gmail.com 
Dr Sharad Agarkhedkar  Dr. D. Y. Patil Medical College, Hospital & Research Centre  Dr. D Y Patil Medical College Hospital and Research Centre, 1st Floor, OPD Complex, Hightech Building, OPD No 12 (Department of Pediatrics), Sant Tukaram Nagar, Pimpri, 411018
Pune
MAHARASHTRA 
9822030122

agarkhedkar@gmail.com 
Dr Shri Harsha Yandapally  Induss Hospital  Induss Hospital, Department of Pediatrics, Ground Floor, Block A, 13-23-93/1, Krishnaveni nagar, Near Gaddiannaram municipal office, Saroornagar,500060
Hyderabad
TELANGANA 
8309060367

harshayandapally10@gmail.com 
Dr Kheya Ghosh Uttam  Institute of Child Health  Institute of Child Health, Ground Floor, Room No. 113, Project Room, 11, Dr. Biresh Guha Street, 700017
Kolkata
WEST BENGAL 
9830297578

kheyauttam@yahoo.co.in 
Dr M D Ravi  JSS Medical College and Hospital  JSS hospital, Department of Pediatrics, 2nd floor, Mahatma Gandhi road, Ramachandra Agrahara 570004
Mysore
KARNATAKA 
9880629506

ravimdped@gmail.com 
Dr Amita Sapru  KEM Hospital Research Centre  Pediatric Research Unit, KEM Hospital Research Centre, TDH Building, 3rd Floor, Sardar Moodliar Road, Rasta Peth, 411011
Pune
MAHARASHTRA 
9822842094

a.sapru@kemhrcpune.org 
Dr Vinay Kumar Gill  Maharaja Agrasen Superspeciality Hospital  Maharaja Agrasen Superspeciality Hospital, Basement, Clinical Research Department, Sector-7, Central Spine, Vidyadhar Nagar, 302039
Jaipur
RAJASTHAN 
9252101110

drvinaykgill@gmail.com 
Dr Sanjay Mankar  Mankar Hospital  Mankar Hospital, Ground Floor, Research Room, Plot no-4, Swaroop Housing Society, Plot No 19, Narveer Tanaji Malusare Road, Anandnagar, 411051,
Pune
MAHARASHTRA 
9422078779

drsanjaym.mankarhospital@gmail.com 
Dr Sandeep Mogre  Meditrina Institute of Medical Sciences  Meditrina Institute of Medical Sciences, Department of Pediatrics, Room No. 7, 1st Floor, 278, Central Bazar Road, Ramdaspeth, 440010
Nagpur
MAHARASHTRA 
9822201872

mogre91@gmail.com 
Dr Vinky Mohanlal Rughwani  Rughwani Child Care Centre and Hospital  Thalassemia and Sickle Cell Centre, Thalassemia Society of Central India, Rughwani Child Care Centre and Hospital, Research Room, Ground Floor, 22 Sindhu Nagar Society, Mohanlal Rughwani Marg, Jaripatka, 440014
Nagpur
MAHARASHTRA 
9370388915

Dr.vinky@yahoo.com 
Dr Sunil Karande  Seth G. S. Medical College and KEM Hospital   Seth G. S. Medical College and KEM Hospital, Department of Pediatrics, Hospital Building, Ground floor, KEM Hospital, 400012
Mumbai
MAHARASHTRA 
9322934309

karandesunil@yahoo.com 
Dr Sathya Moorthy Mani  SRM Medical College Hospital & Research Centre  3rd Floor, Centre for Clinical Trials and Research, SRM Medical College Hospital and Research Centre, SRM Nagar, Kattankulathur-603203, Chengalpattu
Kancheepuram
TAMIL NADU 
9884664592

captsathya@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Institutional Ethics Committee ICH  Approved 
BAPS Hospital Institutional Ethics Committee  Approved 
Ethics Committee of Pulse Multispecialty Hospital  Approved 
Ethics Committee,Dr.D.Y.Patil Vidyapeeth  Submittted/Under Review 
IEC Rughwani Child Care Centre and Hospital  Approved 
IEC, Maharaja Agrasen Hospital, Jaipur  Approved 
INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR  Submittted/Under Review 
Institutional Ethics Committee Induss Hospital, Hyderabad  Approved 
Institutional Ethics Committee JSS Medical College  Approved 
INSTITUTIONAL ETHICS COMMITTEE SRM INSTITUTES FOR MEDICAL SCIENCE  Approved 
Institutional Ethics Committee, Seth GS Medical College and KEM Hospital, Mumbai   Submittted/Under Review 
Institutional Human Ethics Committee , AIIMS , Jodhpur  Submittted/Under Review 
KEM Hospital Research Centre Ethics Committee  Approved 
Meditrina Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Active immunization to develop immunological protection for prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COVAXIN®  COVAXIN® will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly (In 12 to less than 18 years) 
Intervention  GEMCOVAC-19 (COVID-19 vaccine)  In 12 to less than 18 years, GEMCOVAC-19 will be administered as a 2 dose schedule on Day 1 and 29 at 10 micrograms intramuscularly. In 5-11 years , GEMCOVAC-19 will be assesseed in Phase II at 5 and 10 micrograms as a 2 dose regimen intramuscularly. In phase IIII(In 5-11 years), one dose will be selected to be administered as a 2 dose schedule intramuscularly. The study in each age group will last for 9 months 
Comparator Agent  Placebo  0.9% NaCl will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly (In 5 to 11 years)  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Phase II:
1.Male and female subjects’ 5- <18 years.
2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator.
3.Age group 12 - <18 years:
Subject’s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study.
4.Age group: 5 - 11 years:
Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study
5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2
6.Subject/ subject’s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.

Inclusion Criteria for Phase III:
1.Male and female subjects’ 5 - <18 years.
2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator.
3.Age group 12 - <18 years:
Subject’s parent should be capable and willing to give voluntary written informed consent and subject’s should be capable and willing to give voluntary assent form prior to inclusion in the study.
4.Age group: 5 - 11 years:
Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study.
5.Subject’s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
 
 
ExclusionCriteria 
Details  Exclusion Criteria for Phase II: 1.Subject with a recent history of COVID-19 infection within 3 months of Screening. 2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection. 3.Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if ≥ Grade 2 as per DAIDs* criteria * Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health 4.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days 5.Any significant illness or any other current or pre-existing health condition (e.g., any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. 6.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. 7.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination. 8.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. 9.Subjects willing to get married and planning for pregnancy within 4 months of study participation (only applicable for participants of 15 - (smaller than)18 years age). 10.Prior major surgery or any radiation therapy within 4 weeks of Screening visit. 11.Positive serologic test for HIV 1 and 2, HBsAg and HCV. 12.Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). 13.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. 14.Eczema or other significant skin lesion or infection at the site of vaccination. 15.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. 16.Bleeding diathesis or condition associated with prolonged bleeding. 17.Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. 18.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation. Exclusion Criteria for Phase III: 1.Subject with a recent history of COVID-19 infection within 3 months from Screening 2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection. 3.Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. 4.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. 5.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination. 6.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. 7.Subjects who are planning to get married and get pregnant in next 4 months (only applicable for participants of 15 - (smaller than)18 years age). 8.Prior major surgery or any radiation therapy within 4 weeks of Screening visit. 9.A known case of HIV 1 and 2, HBsAg and HCV. 10.Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). 11.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. 12.Eczema or other significant skin lesion or infection at the site of vaccination. 13.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. 14.Bleeding diathesis or condition associated with prolonged bleeding. 15.Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. 16.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation. 
 
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 
Safety (Phase II )
Occurrence and severity of local and systemic reactogenicity adverse events,
unsolicited events and serious adverse events (SAE)

Immunogenicity (Phase II and III)
Age group: 12 - Less than 18 years
Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)]

Immunogenicity (Phase II and III)
Age group: 5 - 11 years
GMT as measured by IgG-ELISA against SARS-CoV-2 Spike protein  
Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study.



At Day 57.





At Day 43.

 
 
Secondary Outcome  
Outcome  TimePoints 
Age Group 12 to less than 18
(Phase II and III)
GMT of anti-spike IgG

GMFR in anti-spike IgG

Proportion seroconverted

Neutralization using cPASS Assay

Cellular Immune Response

Phase III only
Safety, Tolerability and Immunogenicity
 
At Day 57 (28 days post Dose 2), Day 119 and Day 209

At Baseline and Day 57

At Day 57

At Day 57, Day 119 and Day 209 visit

At Day 119 and Day 209 visit


Entire duration of study  
Age Group 5 to 11 year old
(Phase II and III)
GMFR in anti-spike IgG

Proportion seroconverted

Neutralization using PRNT and Cpass

Phase III only
Safety, Tolerability and Immunogenicity
 



Day 43

Day 43

Day 43


Entire duration of study


 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   28/04/2022 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sanjay.singh@gennova.co.in].

  6. For how long will this data be available start date provided 30-04-2023 and end date provided 30-04-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The current study is designed as a prospective, randomized, Phase II study seamlessly followed by a Phase III study in two age groups-12 - <18 years and 5 - 11 years. The study is an active-controlled study with COVAXIN® as the comparator vaccine for age group 12 - <18 years whereas the study is a placebo-controlled study for age group 5 - 11 years. The study will be conducted in 4 parts: Part 1: Phase II in 12 - <18 years age group, Part 2: Phase III in 12 - <18 age group, Part 3: Phase II in 5 - 11 years age group, Part 4: Phase III in 5 - 11 years age group. 
 
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