Created at Source Raw Value Validated value
Sept. 29, 2021, 7 a.m. oms

Positive SARS-CoV-2 antigen test result at Screening or before the first vaccination on Visit 1 (Day 1) .Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacyBody temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccinationPast use of vaccines approved or under development related to SARS-CoV-2 prior to the first vaccination.Past use of immunosuppressive drug within 6 months prior to the first vaccination.Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).

Positive SARS-CoV-2 antigen test result at Screening or before the first vaccination on Visit 1 (Day 1) .Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacyBody temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccinationPast use of vaccines approved or under development related to SARS-CoV-2 prior to the first vaccination.Past use of immunosuppressive drug within 6 months prior to the first vaccination.Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).