Created at Source Raw Value Validated value
Sept. 10, 2021, 3:30 a.m. usa

- positive / uncertain test for sars-cov-2 rna at screening - cohort 1 only. documented history of covid-19. - changes on chest x-ray suggestive for pneumonia or other lung diseases at screening, excluding clinically non-significant changes in subjects with covid-19 history on investigator's opinion. - prior administration of sars-cov-2 or other coronavirus vaccine or planning of receiving sars-cov-2 or other coronavirus vaccine during the study participation. - known contact with sars-cov-2 infected person or person with known contact with sars-cov-2 infected person, within 14 days prior to consent date. - any acute infectious or non-infectious disease, including convalescence period, less than 4 weeks since clinical recovery - positive hiv, hbv, hcv or syphilis tests - history of splenectomy - history of severe allergic reactions - history of allergic or postvaccinal reactions (anaphylactic shock, fever of 40°c or more, fainting, non-febrile convulsions etc.) after vaccine administration - suspicious hypersensitivity or history of hypersensitivity to any component of investigational product - participation in other clinical studies within 90 days prior to consent date, excluding screen failures or discontinued prior to the first investigational product administration.

- positive / uncertain test for sars-cov-2 rna at screening - cohort 1 only. documented history of covid-19. - changes on chest x-ray suggestive for pneumonia or other lung diseases at screening, excluding clinically non-significant changes in subjects with covid-19 history on investigator's opinion. - prior administration of sars-cov-2 or other coronavirus vaccine or planning of receiving sars-cov-2 or other coronavirus vaccine during the study participation. - known contact with sars-cov-2 infected person or person with known contact with sars-cov-2 infected person, within 14 days prior to consent date. - any acute infectious or non-infectious disease, including convalescence period, less than 4 weeks since clinical recovery - positive hiv, hbv, hcv or syphilis tests - history of splenectomy - history of severe allergic reactions - history of allergic or postvaccinal reactions (anaphylactic shock, fever of 40°c or more, fainting, non-febrile convulsions etc.) after vaccine administration - suspicious hypersensitivity or history of hypersensitivity to any component of investigational product - participation in other clinical studies within 90 days prior to consent date, excluding screen failures or discontinued prior to the first investigational product administration.