None listed
Conditions
Interventions
Intervention1: 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.
Control Intervention1:
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 riseTimepoint: 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
| Measure | Time frame |
|---|---|
| Immune response in terms of Geometric mean concentrations and GMFR.Timepoint: From baseline at day 42;Occurrence and severity of any adverse reactionsTimepoint: 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 participantsTimepoint: Up to 28 days post 2nd dose;Occurrence and severity of any unsolicited adverse eventsTimepoint: After each dose till 28 days post vaccination period;Occurrence and severity of solicited symptomsTimepoint: Within 7 consecutive days after each dose;Seroconversion rates in terms of proportion of subjects with =4-fold increaseTimepoint: From baseline at day 42 | — |
Countries
India
Contacts
Public ContactSubba Reddy GV
Biological E.Limited
Outcome results
None listed