COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56105

Dr V Krishna Mohan

kmohan@bharatbiotech.com

2021-05-24

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open 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 (verbal/oral assent for the children of age between 7-12 years, and written assent for the children of age between >12 to 18 years), and Audio video consent for all participants. <br/ >2. Participants of either gender of age between â?¥2 to â?¤18years (Participant should be â?¤18 years at the time of Screening of the study). <br/ >3. Good general health as determined by the discretion of investigator. <br/ >4. Expressed interest and availability to fulfill the study requirements. <br/ >5. Agrees not to participate in another clinical trial at any time during the study period. <br/ >6. Agrees to remain in the study area for the entire duration of the study. <br/ >7. Willing to allow storage and future use of biological samples for future research <br/ >

1. History of any other COVID-19 investigational vaccination. <br/ >2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ >3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >10. Any history of hereditary angioedema or idiopathic angioedema. <br/ >11. Any history of anaphylaxis in relation to vaccination. <br/ >12. History of congenital diseases. <br/ >13. Any history of albumin-intolerance. <br/ >14. History of any cancer. <br/ >15. History of psychiatric severe conditions likely to affect participation in the study. <br/ >16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >17. Any other serious chronic illness requiring hospital specialist supervision. <br/ >18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ >19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ >20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ >21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ >Re-Vaccination Exclusion Criteria <br/ >22. Anaphylactic reaction following administration of the investigational vaccine. <br/ >23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ >

1

Bharat Biotech International Limited

2

18

India

Healthy volunteers

N/A

525

1 Occurrence of immediate adverse events within two hours of vaccination <br/ >2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ >3 Occurrence of Serious Adverse Events throughout the study duration. <br/ >4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ >5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2; 56±7; 118±7 and 208±7

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

Phase 2/Phase 3

[{"arm_notes": "0,5ml;2;Days0-28;IM", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]