COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60393

Subba Reddy GV

kishore.turaga@biologicale.com

2021-10-04

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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. <br/ >2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ >3. Participants of either gender of age between <18years to �5 (Participant should be <18 years at the time of Screening of the study). <br/ >4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ >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]. <br/ >6. Agrees not to participate in another clinical trial at any time during the total study period. <br/ >7. Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ >8. Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ >

1. History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2. Seropositive to IgG antibodies against SARS CoV-2 <br/ >3. Living in the same household of any COVID-19 positive person, <br/ >4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >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), <br/ >6. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment., <br/ >8. Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >9. History of severe psychiatric conditions likely to affect participation in the study, <br/ >10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s CORBEVAX vaccine formulations, <br/ >12. Chronic respiratory disease, including asthma, <br/ >13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >14. Any other serious chronic illness requiring hospital specialist supervision, <br/ >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 â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >18. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >19. Anaphylactic reaction following administration of the investigational vaccine. <br/ >

2

Biological ELimited

5

18

India

Healthy volunteers

N/A

624

Phase II: <br/ >1. Occurrence of any adverse reactions. <br/ >2.The occurrence of solicited symptoms and their severity. <br/ >3. The occurrence of any unsolicited adverse events and their severity. <br/ >4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs). <br/ > <br/ >Phase III: <br/ >1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold riseTimepoint: Phase II: <br/ >1. Within 60 minutes of immediate post vaccination period after each dose. <br/ >2. 7 consecutive days after each dose. <br/ >3.Till 28 days after each post vaccination period. <br/ >4. 28 days after each dose. <br/ > <br/ >Phase III: <br/ >1. from baseline; at day 42.

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 1896, "treatment_name": "Corbevax", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]