Biological E’s CORBEVAX vaccine clinical study for protection against Covid-19 disease in children.
Scientific Title of Study
A Prospective, Randomised, Double-blind, Placebo controlled, Phase-II by III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX Vaccine in Children and Adolescents.
Department of Pulmonology,
1st Floor, Road No.201, Sector-3, Dwarka- 110075 West
09893322007
drakshay.budhraja@aakashhealthcare.com
Dr Pradeep N
Cheluvamba Hospital
Dept. of Paediatrics, ground floor, Cheluvamba Hospital Mysore Medical College & Research Institute, Irwin Road. Mysore
09611898080
drpradeepn80@yahoo.com
Dr M Alexander
Chettinad Hospital And Research Institute,
Department of Paediatrics,
1st Floor, SH 49A, Kelambakkam- 603103 Chennai
09551607900
alexmpaed@gmail.com
Dr Winsley Rose
Christian Medical College
Department of Paediatrics,
5th Floor, IDA Scudder Rd-632004 Vellore
09698884466
winsleyrose@cmcvellore.ac.in
Dr Sharad Agarkhedkar
Dr. D.Y Patil Medical college hospital & Research Centre,
Department of Paediatrics,
2nd Floor, Sant Tukaram Nagar, Pimpri-411018 Pune
09011090078
ashalaka@gmail.com
Dr RN Mandal Ravi
ESIC Medical College & Hospital,
Department of Paediatrics,
Room No. 440, 4th
Floor, NH-3 behind BK Hospital New Industrial
Town -121001 Faridabad
09968604306
rnmravi@yahoo.com
Dr Chandrashekhar S Gillurkar
Gillurkar Multispeciality Hospital
Department of Internal Medicine,3rd Floor, 20, Reshimbag, Umred Road- 440009 Nagpur
09890005678
cgillurkar@yahoo.com
Dr Uday Wasudevrao Narlawar
Government Medical College and Hospital
Department of Community Medicine, 1st floor, Govt Medical College, Hanuman Nagar, Ajani Rd, Medical Chowk, Ajni- 440003 Nagpur
09823133423
udaycon1@rediffmail.com
Dr Manish Narang
Guru Teg Bahadur Hospital & UCMS
Dept. of Paediatrics, 6th floor, MCH Block, Dilshad Garden Shahdara, Delhi - 110095 North East
09811036569
manish_2710@yahoo.com
Dr Sriharsha Yandapally
Induss Hospitals
Department of Paediatrics,
2nd Floor, Near Gaddiannaram Municipal Office, Krishna, Veni Nagar Colony, Kothapet, Sri Sai Shivani Complex, HUDA Complex, Saroornagar- 500035 Hyderabad
09440383778
drvenkat22@gmail.com
Dr Mandyam Dhati Ravi
J.S.S Medical College & Hospital
Department of Pediatrics,Ist floor, Mahathma Gandhi Road-570004 Mysore
09880629506
ravimdped@gmail.com
Dr Abhishek T Chavan
Jeevan Rekha Hospital
Department of Pediatrics,
1st Floor, VGC6 JR9, Ayodhya Nagar, Sadashiv Nagar-590019 Belgaum
09113222185
dr.abhishektchavan@gmail.com
Dr Jay Prakash Narayan
JLN Medical College
Department of Paediatrics,
JLN Medical College ,
2nd Floor, Kala Bagh- 305001 Ajmer
09314294402
narayan_jaiprakash@yahoo.co.in
Dr N S Mahantshetti
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Dept. of Pediatrics, 2nd floor,J N Medical College,Nehru Nagar,590010 Belgaum
09448157237
niranjanakle@gmail.com
Dr Swapnil Taranath
Lifepoint Multispecialty Hospital
Department of Pediatrics,
2nd Floor, No. 145, Sr, 1, Mumbai Pune Bypass Rd, near Sayaji Hotel, Wakad- 411057 Pune
08080724648
jambandhu.swapnil117@gmail.com
Dr Bishan Swarup Garg
Mahatma Gandhi Institute of Medical Sciences (MGIMS)
Department of Community Medicine,
1st Floor, Sewagram- 442102 Wardha
09422141693
gargbs@gmail.com
Dr Pooja Sharma
Medanta Institute of Education and Research
Department of Internal Medicine,
2nd Floor,Sector 38, CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38- 122018 Gurgaon
09811535739
Pooja.Sharma@Medanta.org
Dr Jog Pramod Prabhakar
Medipoint Hospital
Department of Pediatrics,
1st Floor, Plot No 38, Shivraj Chowk, Off, Nagar Rd, near Bhaji Market, Chandan Nagar- 411014 Pune
09422309677
sse.drsushil@gmail.com
Dr Yograj Khinchi
National Institute of Medical Sciences ( NIMS)
Department of Paediatric,
3rd Floor, NH-11C,
Delhi - Jaipur Expressway, Shobha Nagar-303121 Jaipur
09057271273
nims.clinical@gmail.com
Dr Virendra Nath Tripati
Prakhar Hospital
Department of Paediatrics,
4th Floor, 8/219, Khalasi Line, Arya Nagar- 208002 Kanpur Nagar
07906261455
drvntripathi@gmail.com
Dr Monica Gupta
Samvedna Hospital
Department of General Medicine,
3rd Floor, B-27/88-G, New Colony-221005 Varanasi
09415336322
monicag4@yahoo.com
Dr Ramchandra Keshav Dhongade
Sant Dnyaneshwar Medical Education & Research Centre
Department of Paediatrics, ground floor,
695/A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road- 411030 Pune
09011095436
researchadmin@shaishavclinic.com
Dr Madhukar Pandey
Shubham Sudbhawana Super speciality Hospital
Department of Paediatrics,
2nd Floor, B 31/80, 23B - Bhogabeer, Lanka - 221005 Varanasi
09839439464
pandeymadhukar@gmail.com
Dr G Bala Kishor
St. Theresa’s Hospital
Dept. of Paediatrics,1st floor, Sanathnagar-500018 Hyderabad
9949046236
baki2004@gmail.com
Dr Sunil Devichand Lohade
Unique Childrens Hospital
Department of Paediatrics,
3rd Floor, Hira Moti Fortune, Pune - Mumbai Highway, Opposite Chinchwad Police Station, Pimpri-Chinchwad-411019 Pune
Institutional Human Ethics Committee Chettinad Academy of Research and Education
Approved
Institutional Review Board-Sant Dnyaneshwar Medical Education & Research Centre
Approved
IRB Christian Medical college, Vellore
Approved
Lifepoint Research- Ethics Committee
Approved
Medanta Institutional Ethics Committee
Approved
Penta-Med- Ethics Committee
Approved
Samvedna Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Active immunization for the prevention of COVID-19 disease
Intervention / Comparator Agent
Type
Name
Details
Intervention
Biological E’s CORBEVAX Vaccine
Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0, Day 28 and booster dose on Day 208.
Comparator Agent
PLACEBO
Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28
Inclusion Criteria
Age From
5.00 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 aged between ≥7 to <18 years.
2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
3. Participants of either gender of age between <18years to ≥5 (Participant should be <18 years at the time of Screening of the study).
4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment.
5. Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital sign defined as body temperature <100.4ºF prior to enrolment].
6. Agrees not to participate in another clinical trial at any time during the total study period.
7. Agrees to remain in the town where the study centre is located, for the entire duration of the study.
8. Willing to allow storage and future use of collected biological samples for future research in an anonymised form.
ExclusionCriteria
Details
1. History of vaccination with any investigational vaccine against COVID-19 disease;
2. Seropositive to IgG antibodies against SARS CoV-2
3. Living in the same household of any COVID-19 positive person;
4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
5. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
6. Current or planned participation in prophylactic drug trials for the duration of the study.
7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.;
8. Body temperature of ≥100.4°F (>38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination;
9. History of severe psychiatric conditions likely to affect participation in the study;
10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s CORBEVAX vaccine formulations;
12. Chronic respiratory disease, including asthma;
13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
14. Any other serious chronic illness requiring hospital specialist supervision;
15. Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisolone ≥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed;
16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);
17. Any medical condition that in the judgment of the investigator would make study participation unsafe.
18. Individuals who are part of the study team or close family members of individuals conducting the study.
19. Anaphylactic reaction following administration of the investigational vaccine.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Phase II:
1. Occurrence of any adverse reactions.
2.The occurrence of solicited symptoms and their severity.
3. The occurrence of any unsolicited adverse events and their severity.
4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs).
Phase III:
1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold rise
Phase II:
1. Within 60 minutes of immediate post vaccination period after each dose.
2. 7 consecutive days after each dose.
3.Till 28 days after each post vaccination period.
4. 28 days after each dose.
Phase III:
1. from baseline, at day 42.
Secondary Outcome
Outcome
TimePoints
Immune response in terms of Geometric mean concentrations and GMFR.
From baseline at day 42
Occurrence and severity of any adverse reactions
Within 60 minutes of immediate post vaccination period
Occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs) in all study participants
Up to 28 days post 2nd dose
Occurrence and severity of any unsolicited adverse events
After each dose till 28 days post vaccination period
Occurrence and severity of solicited symptoms
Within 7 consecutive days after each dose
Seroconversion rates in terms of proportion of subjects with ≥4-fold increase
From baseline at day 42
Target Sample Size
Total Sample Size="624" Sample Size from India="624"
This is a phase-II seamlessly
followed by phase-III double-blind randomised study to assess safety, tolerability,
reactogenicity and immunogenicity of the Biological E’s CORBEVAXvaccine in children and adolescents aged
between <18 years - ≥5 years with placebo as a control.
The enrolment of subjects will be done in an age stepdown approach with
two age subgroups under each treatment arm viz. age subgroup-1 with subjects
<18 to ≥12 years of age and age subgroup-2 with
subjects <12 to ≥5 years of age. There would be two treatment arms/groups in this study i.e Test Vaccine Group and Placebo Group. All eligible subjects will be randomised by
treatment planned and by age into respective arms.
The study will be conducted in compliance with GSR 227(E),
ICH and Indian good clinical practice guidelines in force at the time of study
conduct.
