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

1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the investigator's judgment, make the participant inappropriate for the study; 3. clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture; 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 prior to injection of first dose; 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 receiving study dose injection; 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.

1. presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the investigator's judgment, make the participant inappropriate for the study; 3. clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture; 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 prior to injection of first dose; 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 receiving study dose injection; 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.

Dec. 16, 2021, 2 a.m. usa

presence of any febrile illness or any known or suspected acute illness on the day of any immunization; any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the investigator's judgment, make the participant inappropriate for the study; clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture; 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 prior to injection of first dose; 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 receiving study dose injection; 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.

presence of any febrile illness or any known or suspected acute illness on the day of any immunization; any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the investigator's judgment, make the participant inappropriate for the study; clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture; 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 prior to injection of first dose; 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 receiving study dose injection; 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.