Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

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,

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,