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

a subject is excluded from this study if any of the following criteria applies: 1. medical history: history of any of the following diseases or conditions: 1. covid-19; 2. sars; 3. any significant respiratory diseases (e.g. copd, asthma); 4. any significant cardiovascular disease (e.g. angina, cardiac arrhythmias); 5. blood dyscrasias or any significant disorder of coagulation; 6. any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis); 7. any chronic infection (e.g. hepatitis b, hepatitis c and hiv); 8. any malignant neoplastic disease; 9. encephalopathy, neuropathy or unstable central nervous system (cns) pathology; 10. any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation; 11. any immunodeficiency or autoimmune disease; 12. any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care; 13. history of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening. 2. medical conditions or diagnoses: existence of any of the following medical conditions or diagnoses: 1. positive serum pregnancy test at screening or positive urine pregnancy test at baseline (only for wocbp); 2. serum fsh test result at screening indicating a postmenopausal status (only for women declaring menopause for at least 12 consecutive months prior to screening); 3. ige level \> 1,000 iu/ml at screening; 4. positive anti-n igg test result at screening; 5. positive sars-cov-2 test result in deep throat saliva (dts) within 4 days prior to the day of vaccination; 6. positive hiv test result at screening; 7. positive hbsag test result at screening; 8. positive hcv antibody test result at screening; 9. positive urine drug screen test result or positive blood alcohol test result at screening or baseline; 10. clinically significant abnormality of t3, t4 or tsh at screening; 11. clinically significant abnormality of pt (inr) or aptt at screening. 3. prior/concomitant interventions: use of or undergoing any of the following prior or concomitant medications, therapies or interventions: 1. any covid-19 or coronavirus vaccine at any time prior to imp vaccination (except the inactivated and mrna vaccines recognized by the local authorities of the respective study sites), or planned use of any such vaccine throughout the study; 2. any vaccine other than covid-19 or coronavirus vaccines within 28 days prior to imp vaccination, or planned use of any such vaccine up to 28 days after imp vaccination; 3. any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to imp vaccination, or planned use of any such medication/therapy throughout the study; 4. any blood product (including blood transfusion) or immunoglobulin within 4 months prior to imp vaccination, or planned use of any such therapy throughout the study; 5. any anticoagulation medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; 6. any psychotropic medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; 7. any prescription or over-the-counter medication within 7 days prior to imp vaccination, unless with the investigator's approval; 8. donated ≥ 450 ml of blood within 28 days prior to imp vaccination. 4. prior/concurrent clinical study: prior or concurrent participation in any other clinical study, including: 1. prior or current participation in another covid-19 vaccine study; 2. prior participation in any interventional clinical study and use of any investigational intervention within 30 days prior to imp vaccination; 3. concurrent participation or plan for participation in another interventional clinical study during participation in this study. 5. other significant medical conditions: any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study. 6. special condition: existence of the following special condition: 1. planned to travel overseas at any time during the period from screening to day 90(±7) visit.

a subject is excluded from this study if any of the following criteria applies: 1. medical history: history of any of the following diseases or conditions: 1. covid-19; 2. sars; 3. any significant respiratory diseases (e.g. copd, asthma); 4. any significant cardiovascular disease (e.g. angina, cardiac arrhythmias); 5. blood dyscrasias or any significant disorder of coagulation; 6. any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis); 7. any chronic infection (e.g. hepatitis b, hepatitis c and hiv); 8. any malignant neoplastic disease; 9. encephalopathy, neuropathy or unstable central nervous system (cns) pathology; 10. any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation; 11. any immunodeficiency or autoimmune disease; 12. any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care; 13. history of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening. 2. medical conditions or diagnoses: existence of any of the following medical conditions or diagnoses: 1. positive serum pregnancy test at screening or positive urine pregnancy test at baseline (only for wocbp); 2. serum fsh test result at screening indicating a postmenopausal status (only for women declaring menopause for at least 12 consecutive months prior to screening); 3. ige level \> 1,000 iu/ml at screening; 4. positive anti-n igg test result at screening; 5. positive sars-cov-2 test result in deep throat saliva (dts) within 4 days prior to the day of vaccination; 6. positive hiv test result at screening; 7. positive hbsag test result at screening; 8. positive hcv antibody test result at screening; 9. positive urine drug screen test result or positive blood alcohol test result at screening or baseline; 10. clinically significant abnormality of t3, t4 or tsh at screening; 11. clinically significant abnormality of pt (inr) or aptt at screening. 3. prior/concomitant interventions: use of or undergoing any of the following prior or concomitant medications, therapies or interventions: 1. any covid-19 or coronavirus vaccine at any time prior to imp vaccination (except the inactivated and mrna vaccines recognized by the local authorities of the respective study sites), or planned use of any such vaccine throughout the study; 2. any vaccine other than covid-19 or coronavirus vaccines within 28 days prior to imp vaccination, or planned use of any such vaccine up to 28 days after imp vaccination; 3. any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to imp vaccination, or planned use of any such medication/therapy throughout the study; 4. any blood product (including blood transfusion) or immunoglobulin within 4 months prior to imp vaccination, or planned use of any such therapy throughout the study; 5. any anticoagulation medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; 6. any psychotropic medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; 7. any prescription or over-the-counter medication within 7 days prior to imp vaccination, unless with the investigator's approval; 8. donated ≥ 450 ml of blood within 28 days prior to imp vaccination. 4. prior/concurrent clinical study: prior or concurrent participation in any other clinical study, including: 1. prior or current participation in another covid-19 vaccine study; 2. prior participation in any interventional clinical study and use of any investigational intervention within 30 days prior to imp vaccination; 3. concurrent participation or plan for participation in another interventional clinical study during participation in this study. 5. other significant medical conditions: any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study. 6. special condition: existence of the following special condition: 1. planned to travel overseas at any time during the period from screening to day 90(±7) visit.

Nov. 9, 2022, 4 p.m. usa

a subject is excluded from this study if any of the following criteria applies: medical history: history of any of the following diseases or conditions: covid-19; sars; any significant respiratory diseases (e.g. copd, asthma); any significant cardiovascular disease (e.g. angina, cardiac arrhythmias); blood dyscrasias or any significant disorder of coagulation; any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis); any chronic infection (e.g. hepatitis b, hepatitis c and hiv); any malignant neoplastic disease; encephalopathy, neuropathy or unstable central nervous system (cns) pathology; any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation; any immunodeficiency or autoimmune disease; any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care; history of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening. medical conditions or diagnoses: existence of any of the following medical conditions or diagnoses: positive serum pregnancy test at screening or positive urine pregnancy test at baseline (only for wocbp); serum fsh test result at screening indicating a postmenopausal status (only for women declaring menopause for at least 12 consecutive months prior to screening); ige level > 1,000 iu/ml at screening; positive anti-n igg test result at screening; positive sars-cov-2 test result in deep throat saliva (dts) within 4 days prior to the day of vaccination; positive hiv test result at screening; positive hbsag test result at screening; positive hcv antibody test result at screening; positive urine drug screen test result or positive blood alcohol test result at screening or baseline; clinically significant abnormality of t3, t4 or tsh at screening; clinically significant abnormality of pt (inr) or aptt at screening. prior/concomitant interventions: use of or undergoing any of the following prior or concomitant medications, therapies or interventions: any covid-19 or coronavirus vaccine at any time prior to imp vaccination (except the inactivated and mrna vaccines recognized by the local authorities of the respective study sites), or planned use of any such vaccine throughout the study; any vaccine other than covid-19 or coronavirus vaccines within 28 days prior to imp vaccination, or planned use of any such vaccine up to 28 days after imp vaccination; any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to imp vaccination, or planned use of any such medication/therapy throughout the study; any blood product (including blood transfusion) or immunoglobulin within 4 months prior to imp vaccination, or planned use of any such therapy throughout the study; any anticoagulation medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; any psychotropic medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; any prescription or over-the-counter medication within 7 days prior to imp vaccination, unless with the investigator's approval; donated ≥ 450 ml of blood within 28 days prior to imp vaccination. prior/concurrent clinical study: prior or concurrent participation in any other clinical study, including: prior or current participation in another covid-19 vaccine study; prior participation in any interventional clinical study and use of any investigational intervention within 30 days prior to imp vaccination; concurrent participation or plan for participation in another interventional clinical study during participation in this study. other significant medical conditions: any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study. special condition: existence of the following special condition: planned to travel overseas at any time during the period from screening to day 90(±7) visit.

a subject is excluded from this study if any of the following criteria applies: medical history: history of any of the following diseases or conditions: covid-19; sars; any significant respiratory diseases (e.g. copd, asthma); any significant cardiovascular disease (e.g. angina, cardiac arrhythmias); blood dyscrasias or any significant disorder of coagulation; any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis); any chronic infection (e.g. hepatitis b, hepatitis c and hiv); any malignant neoplastic disease; encephalopathy, neuropathy or unstable central nervous system (cns) pathology; any psychiatric disorder, psychotic disorder, major affective disorder or suicidal ideation; any immunodeficiency or autoimmune disease; any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance, which requires hospitalization or emergency medical care; history of alcohol or illicit drug abuse, or used any illicit drug within 6 months prior to screening. medical conditions or diagnoses: existence of any of the following medical conditions or diagnoses: positive serum pregnancy test at screening or positive urine pregnancy test at baseline (only for wocbp); serum fsh test result at screening indicating a postmenopausal status (only for women declaring menopause for at least 12 consecutive months prior to screening); ige level > 1,000 iu/ml at screening; positive anti-n igg test result at screening; positive sars-cov-2 test result in deep throat saliva (dts) within 4 days prior to the day of vaccination; positive hiv test result at screening; positive hbsag test result at screening; positive hcv antibody test result at screening; positive urine drug screen test result or positive blood alcohol test result at screening or baseline; clinically significant abnormality of t3, t4 or tsh at screening; clinically significant abnormality of pt (inr) or aptt at screening. prior/concomitant interventions: use of or undergoing any of the following prior or concomitant medications, therapies or interventions: any covid-19 or coronavirus vaccine at any time prior to imp vaccination (except the inactivated and mrna vaccines recognized by the local authorities of the respective study sites), or planned use of any such vaccine throughout the study; any vaccine other than covid-19 or coronavirus vaccines within 28 days prior to imp vaccination, or planned use of any such vaccine up to 28 days after imp vaccination; any immune-modifying medication/therapy (e.g. immunomodulator and immunosuppressant) within 6 months prior to imp vaccination, or planned use of any such medication/therapy throughout the study; any blood product (including blood transfusion) or immunoglobulin within 4 months prior to imp vaccination, or planned use of any such therapy throughout the study; any anticoagulation medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; any psychotropic medication within 28 days prior to imp vaccination, or planned use of any such medication up to 28 days after imp vaccination; any prescription or over-the-counter medication within 7 days prior to imp vaccination, unless with the investigator's approval; donated ≥ 450 ml of blood within 28 days prior to imp vaccination. prior/concurrent clinical study: prior or concurrent participation in any other clinical study, including: prior or current participation in another covid-19 vaccine study; prior participation in any interventional clinical study and use of any investigational intervention within 30 days prior to imp vaccination; concurrent participation or plan for participation in another interventional clinical study during participation in this study. other significant medical conditions: any clinically significant concomitant disease or condition that, in the reasonable opinion of the investigator, may interfere with the subject's participation in this study or pose an unacceptable safety risk for the subject's participation in this study. special condition: existence of the following special condition: planned to travel overseas at any time during the period from screening to day 90(±7) visit.