Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

1. History of any other COVID-19 investigational/or licensed vaccination. <br/ > 2. For women of child bearing potential, a positive serum pregnancy test (during <br/ > screening within 45 days of enrolment) or positive urine pregnancy test (within <br/ > 24 hours of administering each dose of vaccine). <br/ > 3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness <br/ > such as an upper respiratory infection or gastroenteritis within three days prior <br/ > to each dose of vaccine. <br/ > 4. Medical problems because of alcohol or illicit drug use during the past 12 <br/ > months. <br/ > 5. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ > before enrolment or expects to receive an investigational agent during the <br/ > study period. <br/ > 6. Receipt of any licensed vaccine within four weeks before enrolment in this <br/ > study. <br/ > 7. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ > allergic reaction and history of allergies in the past. <br/ > 8. Receipt of immunoglobulin or other blood products within the three months <br/ > prior to vaccination in this study. <br/ > 9. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or <br/ > radiation therapy within the preceding 36 months. <br/ > 10. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or <br/ > high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or <br/ > equivalent) within the preceding six months (nasal and topical steroids are <br/ > allowed). <br/ > 11. Any history of anaphylaxis in relation to vaccination. <br/ > 12. History of any cancer. <br/ > 13. History of severe psychiatric conditions likely to affect participation in the <br/ > study. <br/ > 14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, <br/ > or prior history of significant bleeding or bruising following IM injections or <br/ > venepuncture). <br/ > 15. Any other serious chronic illness requiring immediate hospital specialist <br/ > supervision. <br/ > 16. Any other condition that in the opinion of the investigator would jeopardize <br/ > the safety or rights of a volunteer participating in the trial or would render the <br/ > subject unable to comply with the protocol

1. History of any other COVID-19 investigational/or licensed vaccination. <br/ > 2. For women of child bearing potential, a positive serum pregnancy test (during <br/ > screening within 45 days of enrolment) or positive urine pregnancy test (within <br/ > 24 hours of administering each dose of vaccine). <br/ > 3. Temperature >38.0°C (100.4°F) or symptoms of an acute self limiting illness <br/ > such as an upper respiratory infection or gastroenteritis within three days prior <br/ > to each dose of vaccine. <br/ > 4. Medical problems because of alcohol or illicit drug use during the past 12 <br/ > months. <br/ > 5. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ > before enrolment or expects to receive an investigational agent during the <br/ > study period. <br/ > 6. Receipt of any licensed vaccine within four weeks before enrolment in this <br/ > study. <br/ > 7. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ > allergic reaction and history of allergies in the past. <br/ > 8. Receipt of immunoglobulin or other blood products within the three months <br/ > prior to vaccination in this study. <br/ > 9. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of anticancer chemotherapy or <br/ > radiation therapy within the preceding 36 months. <br/ > 10. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or <br/ > high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or <br/ > equivalent) within the preceding six months (nasal and topical steroids are <br/ > allowed). <br/ > 11. Any history of anaphylaxis in relation to vaccination. <br/ > 12. History of any cancer. <br/ > 13. History of severe psychiatric conditions likely to affect participation in the <br/ > study. <br/ > 14. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, <br/ > or prior history of significant bleeding or bruising following IM injections or <br/ > venepuncture). <br/ > 15. Any other serious chronic illness requiring immediate hospital specialist <br/ > supervision. <br/ > 16. Any other condition that in the opinion of the investigator would jeopardize <br/ > the safety or rights of a volunteer participating in the trial or would render the <br/ > subject unable to comply with the protocol