Created at Source Raw Value Validated value
Dec. 5, 2020, 12:45 a.m. oms

Participants are not eligible for the trial if any of the following criteria are met: E01: Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure E02: Receipt of any vaccine in the 30 days preceding or on the day of the first trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention a. E03: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]) E04: Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances b. E05: Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee’s judgment E06: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator or designee’s judgment E07: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator or designee’s judgment E08: Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily E09: Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the trial procedures E10: Receipt of solid-organ or bone marrow transplants in the past 180 days E11: Receipt of anti-cancer chemotherapy in the last 90 days

Participants are not eligible for the trial if any of the following criteria are met: E01: Participation at the time of trial enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure E02: Receipt of any vaccine in the 30 days preceding or on the day of the first trial vaccination or planned receipt of any vaccine in the 30 days following the second trial vaccination except for influenza vaccination, which may be received at any time in relation to trial intervention a. E03: Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]) E04: Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances b. E05: Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee’s judgment E06: Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator or designee’s judgment E07: Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator or designee’s judgment E08: Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily E09: Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the trial procedures E10: Receipt of solid-organ or bone marrow transplants in the past 180 days E11: Receipt of anti-cancer chemotherapy in the last 90 days