Created at Source Raw Value Validated value
June 17, 2021, 12:45 a.m. oms

Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part:-Positive SARS-CoV-2 antigen test result at Screening.-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 efficacy-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.-Past use of vaccines related to SARS-CoV-2 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).Phase 1 Part-A and Phase 1 Part-C:-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 vaccination.-Past use of immunosuppressive drug within 6 months prior to the first vaccination.The following applies to Phase 1 Part-B and Phase 2 Part:-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.

Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part:-Positive SARS-CoV-2 antigen test result at Screening.-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 efficacy-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.-Past use of vaccines related to SARS-CoV-2 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).Phase 1 Part-A and Phase 1 Part-C:-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 vaccination.-Past use of immunosuppressive drug within 6 months prior to the first vaccination.The following applies to Phase 1 Part-B and Phase 2 Part:-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.

Jan. 8, 2021, 12:45 a.m. oms

Both Phase 1 Part and Phase 2 Part:-Positive SARS-CoV-2 antigen test result at Screening.-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 efficacy-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.-Past use of vaccines related to SARS-CoV-2 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).Phase 1 Part:-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 vaccination.-Past use of immunosuppressive drug within 6 months prior to the first vaccination.Phase 2 Part:-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.

Both Phase 1 Part and Phase 2 Part:-Positive SARS-CoV-2 antigen test result at Screening.-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 efficacy-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.-Past use of vaccines related to SARS-CoV-2 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).Phase 1 Part:-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 vaccination.-Past use of immunosuppressive drug within 6 months prior to the first vaccination.Phase 2 Part:-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.