Created at Source Raw Value Validated value
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.