Created at Source Raw Value Validated value
March 4, 2021, 12:45 a.m. oms

- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).- Receipt of medications intended to prevent COVID-19.- Previous clinical or microbiological diagnosis of COVID-19.- Individuals at high risk for severe COVID-19, who are planned to receive COVID vaccine within the next two months.- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history.- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.- Receipt of systemic or topical corticosteroids.- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.- Women who are pregnant or breastfeeding.- Planned pregnancy within four weeks after the final injection.- Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.- SARS-CoV-2 PCR-positive nasopharyngeal/throat swab at the screening before receipt of first vaccine dose.- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.- Receipt of any other non-study vaccine within 28 days, before first study dose.- Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration

- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).- Receipt of medications intended to prevent COVID-19.- Previous clinical or microbiological diagnosis of COVID-19.- Individuals at high risk for severe COVID-19, who are planned to receive COVID vaccine within the next two months.- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history.- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.- Receipt of systemic or topical corticosteroids.- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.- Women who are pregnant or breastfeeding.- Planned pregnancy within four weeks after the final injection.- Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.- SARS-CoV-2 PCR-positive nasopharyngeal/throat swab at the screening before receipt of first vaccine dose.- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.- Receipt of any other non-study vaccine within 28 days, before first study dose.- Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration