Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1. History of any other COVID-19 investigational vaccination. <br/ >2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ >3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >10. Any history of hereditary angioedema or idiopathic angioedema. <br/ >11. Any history of anaphylaxis in relation to vaccination. <br/ >12. History of congenital diseases. <br/ >13. Any history of albumin-intolerance. <br/ >14. History of any cancer. <br/ >15. History of psychiatric severe conditions likely to affect participation in the study. <br/ >16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >17. Any other serious chronic illness requiring hospital specialist supervision. <br/ >18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ >19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ >20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ >21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ >Re-Vaccination Exclusion Criteria <br/ >22. Anaphylactic reaction following administration of the investigational vaccine. <br/ >23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ >

1. History of any other COVID-19 investigational vaccination. <br/ >2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ >3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >10. Any history of hereditary angioedema or idiopathic angioedema. <br/ >11. Any history of anaphylaxis in relation to vaccination. <br/ >12. History of congenital diseases. <br/ >13. Any history of albumin-intolerance. <br/ >14. History of any cancer. <br/ >15. History of psychiatric severe conditions likely to affect participation in the study. <br/ >16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >17. Any other serious chronic illness requiring hospital specialist supervision. <br/ >18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ >19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ >20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ >21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ >Re-Vaccination Exclusion Criteria <br/ >22. Anaphylactic reaction following administration of the investigational vaccine. <br/ >23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ >

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

1. History of any other COVID-19 investigational vaccination. <br/ >2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ >3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >10. Any history of hereditary angioedema or idiopathic angioedema. <br/ >11. Any history of anaphylaxis in relation to vaccination. <br/ >12. History of congenital diseases. <br/ >13. Any history of albumin-intolerance. <br/ >14. History of any cancer. <br/ >15. History of psychiatric severe conditions likely to affect participation in the study. <br/ >16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >17. Any other serious chronic illness requiring hospital specialist supervision. <br/ >18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ >19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ >20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ >21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ >Re-Vaccination Exclusion Criteria <br/ >22. Anaphylactic reaction following administration of the investigational vaccine. <br/ >23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ >

1. History of any other COVID-19 investigational vaccination. <br/ >2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ >3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ >5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ >9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ >10. Any history of hereditary angioedema or idiopathic angioedema. <br/ >11. Any history of anaphylaxis in relation to vaccination. <br/ >12. History of congenital diseases. <br/ >13. Any history of albumin-intolerance. <br/ >14. History of any cancer. <br/ >15. History of psychiatric severe conditions likely to affect participation in the study. <br/ >16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ >17. Any other serious chronic illness requiring hospital specialist supervision. <br/ >18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ >19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ >20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ >21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ >Re-Vaccination Exclusion Criteria <br/ >22. Anaphylactic reaction following administration of the investigational vaccine. <br/ >23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ >