Institutional Human Ethics Committee Chettinad Academy of Research and Education
Institutional Review Board-Sant Dnyaneshwar Medical Education & Research Centre
IRB Christian Medical college, Vellore
Lifepoint Research- Ethics Committee
Medanta Institutional Ethics Committee
Penta-Med- Ethics Committee
Samvedna Hospital Ethics Committee
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied
Healthy Human Volunteers
Active immunization for the prevention of COVID-19 disease
Intervention / Comparator Agent
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.
Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28
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.
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
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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).
1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold rise
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.
1. from baseline, at day 42.
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