Created at Source Raw Value Validated value
Nov. 12, 2021, 5:03 p.m. oms

1. History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2. Seropositive to IgG antibodies against SARS CoV-2 <br/ >3. Living in the same household of any COVID-19 positive person, <br/ >4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >5. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >6. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment., <br/ >8. Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >9. History of severe psychiatric conditions likely to affect participation in the study, <br/ >10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s CORBEVAX vaccine formulations, <br/ >12. Chronic respiratory disease, including asthma, <br/ >13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >14. Any other serious chronic illness requiring hospital specialist supervision, <br/ >15. Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisolone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >18. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >19. Anaphylactic reaction following administration of the investigational vaccine. <br/ >

1. History of vaccination with any investigational vaccine against COVID-19 disease, <br/ >2. Seropositive to IgG antibodies against SARS CoV-2 <br/ >3. Living in the same household of any COVID-19 positive person, <br/ >4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment, <br/ >5. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines), <br/ >6. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ >7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment., <br/ >8. Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination, <br/ >9. History of severe psychiatric conditions likely to affect participation in the study, <br/ >10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), <br/ >11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s CORBEVAX vaccine formulations, <br/ >12. Chronic respiratory disease, including asthma, <br/ >13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, <br/ >14. Any other serious chronic illness requiring hospital specialist supervision, <br/ >15. Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisolone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed, <br/ >16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), <br/ >17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >18. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ >19. Anaphylactic reaction following administration of the investigational vaccine. <br/ >