COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04918797

Not reported

Not reported

2021-06-09

Completed

nonRCT

Non-randomized

Single group assignment

Open label

multi-center

Prevention

inclusion criteria: 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. participants of either gender of age between ≥2 to ≤18years (participant should be ≤18 years at the time of screening of the study). good general health as determined by the discretion of investigator. expressed interest and availability to fulfill the study requirements. agrees not to participate in another clinical trial at any time during the study period. agrees to remain in the study area for the entire duration of the study. willing to allow storage and future use of biological samples for future research.

history of any other covid-19 investigational vaccination. confirmed sars-cov-2 at the time of screening using rt-pcr and elisa method. 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. 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. receipt of any licensed vaccine within four weeks before enrollment in this study. known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. 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. 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). any history of hereditary angioedema or idiopathic angioedema. any history of anaphylaxis in relation to vaccination. history of congenital diseases. any history of albumin-intolerance. history of any cancer. history of psychiatric severe conditions likely to affect participation in the study. a bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following im injections or venepuncture. any other serious chronic illness requiring hospital specialist supervision. respiratory diseases like severe acute respiratory syndrome (sars), including mild asthma. chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness 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. 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. re-vaccination exclusion criteria anaphylactic reaction following administration of the investigational vaccine. virologically confirmed cases of covid-19

1

Bharat Biotech International Limited

2

18

India

Healthy volunteers

N/A

525

Immunogenecity;Reactogenicity

None

Phase 2/Phase 3

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