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

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

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

participant with any of the following criteria will be excluded: presence of any febrile illness or any known or suspected acute illness on the day of any immunization; any physical findings suggestive of acute or chronic illness; any immunodeficiency (congenital or acquired); receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; presence of autoimmune disease; receipt of any investigational drug within 6 months; receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; receipt of any authorized covid-19 vaccine prior to study enrollment; receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; current anti-tuberculosis therapy; history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

participant with any of the following criteria will be excluded: presence of any febrile illness or any known or suspected acute illness on the day of any immunization; any physical findings suggestive of acute or chronic illness; any immunodeficiency (congenital or acquired); receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; presence of autoimmune disease; receipt of any investigational drug within 6 months; receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; receipt of any authorized covid-19 vaccine prior to study enrollment; receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; current anti-tuberculosis therapy; history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

July 8, 2021, 4 a.m. usa

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

April 6, 2021, 12:31 a.m. usa

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known positive serology.

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; 10. receipt of any authorized covid-19 vaccine prior to study enrollment; 11. receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 13. current anti-tuberculosis therapy; 14. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 15. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 16. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known positive serology.

Jan. 10, 2021, 12:31 a.m. usa

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any authorized vaccines within 2 weeks of study immunization; 10. receipt of any other sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 11. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 12. current anti-tuberculosis therapy; 13. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 14. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 15. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known positive serology.

participant with any of the following criteria will be excluded: 1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any physical findings suggestive of acute or chronic illness; 3. any immunodeficiency (congenital or acquired); 4. receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; 5. receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; 6. cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; 7. presence of autoimmune disease; 8. receipt of any investigational drug within 6 months; 9. receipt of any authorized vaccines within 2 weeks of study immunization; 10. receipt of any other sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 11. receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; 12. current anti-tuberculosis therapy; 13. history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; 14. hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; 15. known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known positive serology.