Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

positive rt-pcr test result for sars-cov-2 infection at screening or baseline positive serology test result for anti-sars-cov-2 antibodies at screening or baseline covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol received intravenous immunoglobulin (ivig) or blood products in the last 3 months any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening clinical history of myocarditis and/or pericarditis note: other protocol-defined inclusion/ exclusion criteria apply

positive rt-pcr test result for sars-cov-2 infection at screening or baseline positive serology test result for anti-sars-cov-2 antibodies at screening or baseline covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol received intravenous immunoglobulin (ivig) or blood products in the last 3 months any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening clinical history of myocarditis and/or pericarditis note: other protocol-defined inclusion/ exclusion criteria apply

Oct. 25, 2021, 10:30 a.m. usa

1. positive rt-pcr test result for sars-cov-2 infection at screening or baseline 2. positive serology test result for anti-sars-cov-2 antibodies at screening or baseline 3. covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening 4. previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) 5. currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 6. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol 7. received intravenous immunoglobulin (ivig) or blood products in the last 3 months 8. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation 9. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation 10. medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening 11. clinical history of myocarditis and/or pericarditis note: other protocol-defined inclusion/ exclusion criteria apply

1. positive rt-pcr test result for sars-cov-2 infection at screening or baseline 2. positive serology test result for anti-sars-cov-2 antibodies at screening or baseline 3. covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening 4. previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) 5. currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 6. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol 7. received intravenous immunoglobulin (ivig) or blood products in the last 3 months 8. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation 9. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation 10. medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening 11. clinical history of myocarditis and/or pericarditis note: other protocol-defined inclusion/ exclusion criteria apply

April 23, 2021, 12:31 a.m. usa

1. positive rt-pcr test result for sars-cov-2 infection at screening or baseline 2. positive serology test result for anti-sars-cov-2 antibodies at screening or baseline 3. covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening 4. previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) 5. currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 6. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol 7. received intravenous immunoglobulin (ivig) or blood products in the last 3 months 8. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation 9. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation 10. medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening note: other protocol-defined inclusion/ exclusion criteria apply

1. positive rt-pcr test result for sars-cov-2 infection at screening or baseline 2. positive serology test result for anti-sars-cov-2 antibodies at screening or baseline 3. covid-19 diagnosis, positive sars-cov-2 infection, or positive sars-cov-2 serology at any time prior to screening 4. previously received an investigational, authorized, or approved coronavirus vaccine (eg, sars-cov-2 vaccine, mers-cov vaccine) 5. currently enrolled in, or has plans to enroll in, any interventional study to prevent or treat covid-19 6. received investigational or approved passive antibodies for sars-cov-2 infection prophylaxis ad defined in the protocol 7. received intravenous immunoglobulin (ivig) or blood products in the last 3 months 8. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by study participation 9. history of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or pose an additional risk to the subject by study participation 10. medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening note: other protocol-defined inclusion/ exclusion criteria apply