COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=65451

Dr Krishna Mohan

kmohan@bharatbiotech.com

2022-02-03

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1. Ability to provide written informed consent. <br/ > 2. Participants of either gender of age �18 years. <br/ > 3. Received and completed Coronavirus Disease 2019 vaccine under Emergency Use <br/ > Authorization (EUA) dosing guidelines at least 6 ± 1month (after receipt of second dose of EUA <br/ > vaccine) prior to enrollment, confirmed by the electronic Covid-19 Certificate (CoWIN). <br/ > 4. Expressed interest and availability to fulfill the study requirements. <br/ > 5. For a female participant of child-bearing potential, planning to avoid becoming pregnant <br/ > (use of an effective method of contraception or abstinence) from the time of study enrolment until at <br/ > least four weeks after vaccination <br/ > 6. Agrees not to participate in another clinical trial at any time during the study period. <br/ > 7. Agrees to remain in the study area for the entire duration of the study. <br/ > 8. Willing to allow storage and future use of biological samples for future research

1. Known history of COVID-19 infection. <br/ > 2. For women of child bearing potential, a positive serum pregnancy test (during screening <br/ > within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering <br/ > vaccine). <br/ > 3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness such as an <br/ > upper respiratory infection or gastroenteritis within three days prior to vaccination. <br/ > 4. Medical problems because of alcohol or illicit drug use during the past 12 months. <br/ > 5. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before <br/ > enrolment or expects to receive an investigational agent during the study period. <br/ > 6. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ > 7. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction <br/ > and history of allergies in the past. <br/ > 8. Receipt of immunoglobulin or other blood products within the three months prior to <br/ > vaccination in this study. <br/ > 9. Immunosuppression because of an underlying illness or treatment with immunosuppressive <br/ > or cytotoxic drugs or use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ > months. <br/ > 10. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose <br/ > inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding <br/ > six months (nasal and topical steroids are allowed). <br/ > 11. Any history of anaphylaxis in relation to vaccination. <br/ > 12. History of any cancer. <br/ > 13. History of severe psychiatric conditions likely to affect participation in the study. <br/ > 14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history <br/ > of significant bleeding or bruising following IM injections or venepuncture). <br/ > 15. Any other serious chronic illness requiring immediate hospital specialist supervision. <br/ > 16. Any other condition that in the opinion of the investigator would jeopardize the safety or <br/ > rights of a volunteer participating in the trial or would render the subject unable to comply with the <br/ > protocol.

3

Bharat Biotech International Limited

18

65

India

Healthy volunteers

N/A

875

1. Geometric mean titres (GMTs) of serum neutralising antibody titer (NAbâ??s) by Neutralising Antibody <br/ >Assays <br/ >Timepoint: 1. Day 0 ; 28 and 56 <br/ >

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 3

[{"arm_notes": "", "treatment_id": 185, "treatment_name": "Bbv154", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]