Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. receiving any investigational intervention either currently or within 30 days of first dose; 2. subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; 3. administration of any vaccine within 4 weeks of first dose; 4. a bmi greater than or equal to 30 kg/m2; 5. subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; 6. administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; 7. pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; 8. history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; 9. positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); 10. baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; 11. screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); 12. immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 13. a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); 14. current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; 15. current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; 16. prior major surgery or any radiation therapy within 12 weeks of first dose; 17. alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; 18. presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; 19. body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; 20. screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; 21. abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.

1. receiving any investigational intervention either currently or within 30 days of first dose; 2. subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; 3. administration of any vaccine within 4 weeks of first dose; 4. a bmi greater than or equal to 30 kg/m2; 5. subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; 6. administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; 7. pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; 8. history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; 9. positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); 10. baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; 11. screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); 12. immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 13. a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); 14. current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; 15. current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; 16. prior major surgery or any radiation therapy within 12 weeks of first dose; 17. alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; 18. presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; 19. body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; 20. screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; 21. abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.

Nov. 16, 2021, 6:30 p.m. usa

receiving any investigational intervention either currently or within 30 days of first dose; subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; administration of any vaccine within 4 weeks of first dose; a bmi greater than or equal to 30 kg/m2; subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; prior major surgery or any radiation therapy within 12 weeks of first dose; alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.

receiving any investigational intervention either currently or within 30 days of first dose; subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; administration of any vaccine within 4 weeks of first dose; a bmi greater than or equal to 30 kg/m2; subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; prior major surgery or any radiation therapy within 12 weeks of first dose; alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.

Oct. 26, 2020, 11:31 p.m. usa

1. receiving any investigational intervention either currently or within 30 days of first dose; 2. subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; 3. administration of any vaccine within 4 weeks of first dose; 4. a bmi greater than or equal to 30 kg/m2; 5. subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; 6. administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; 7. pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; 8. history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; 9. positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); 10. baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; 11. screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); 12. immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 13. a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); 14. current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; 15. current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; 16. prior major surgery or any radiation therapy within 12 weeks of first dose; 17. alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; 18. presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; 19. body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; 20. screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; 21. abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.

1. receiving any investigational intervention either currently or within 30 days of first dose; 2. subject (particularly who is a healthcare worker) with previous known or potential exposure to sars cov-1 or 2 viruses (except for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other covid-19 vaccine; 3. administration of any vaccine within 4 weeks of first dose; 4. a bmi greater than or equal to 30 kg/m2; 5. subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the mvc-cov1901; 6. administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose; 7. pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines; 8. history of positive serologic test for hiv, hepatitis b surface antigen (hbsag) or any potentially communicable infectious disease as determined by the investigator or medical monitor; 9. positive serologic test for hepatitis c (exception: successful treatment with confirmation of sustained virologic response); 10. baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dl; 11. screening laboratory tests with grade 2 or higher abnormality (toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, september 2007); 12. immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation; 13. a history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.); 14. current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose; 15. current or anticipated treatment with tnf-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose; 16. prior major surgery or any radiation therapy within 12 weeks of first dose; 17. alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint; 18. presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area; 19. body (oral, rectal or ear) temperature ≥ 38.0°c or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose; 20. screening laboratory test of antinuclear antibody (ana), anti-dsdna antibody, anti-neutrophil cytoplasmic antibodies (anca, including cytoplasmic anca (c-anca), perinuclear anca (p-anca)) with the value higher than upper normal limit; 21. abnormal screening electrocardiography (ecg) with clinically significant findings as reviewed by investigator.