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

Phase 1: <br/ >1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ >or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ >(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ >care provider for follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ >4. Health care workers. <br/ >5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ >6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ >such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ >8. 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/ >9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >12. 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/ >13. 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/ >14. Any history of hereditary angioedema or idiopathic angioedema. <br/ >15. Any history of anaphylaxis in relation to vaccination. <br/ >16. Any history of albumin-intolerance. <br/ >17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ >18. History of any cancer. <br/ >19. History of psychiatric severe conditions likely to affect participation in the study. <br/ >20. 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/ >21. Any other serious chronic illness requiring hospital specialist supervision. <br/ >22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ >23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ >24. Morbidly obese (BMI�35 kg/m2) or underweight (BMI �18 kg/m2). <br/ >25. Living in the same household of any COVID-19 positive person. <br/ >26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights

Phase 1: <br/ >1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ >or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ >(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ >care provider for follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ >4. Health care workers. <br/ >5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ >6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ >such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ >8. 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/ >9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >12. 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/ >13. 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/ >14. Any history of hereditary angioedema or idiopathic angioedema. <br/ >15. Any history of anaphylaxis in relation to vaccination. <br/ >16. Any history of albumin-intolerance. <br/ >17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ >18. History of any cancer. <br/ >19. History of psychiatric severe conditions likely to affect participation in the study. <br/ >20. 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/ >21. Any other serious chronic illness requiring hospital specialist supervision. <br/ >22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ >23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ >24. Morbidly obese (BMI�35 kg/m2) or underweight (BMI �18 kg/m2). <br/ >25. Living in the same household of any COVID-19 positive person. <br/ >26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights

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

N/A

N/A

July 30, 2021, 1:30 p.m. oms

Phase 1: <br/ >1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ >or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ >(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ >care provider for follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ >4. Health care workers. <br/ >5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ >6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ >such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ >8. 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/ >9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >12. 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/ >13. 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/ >14. Any history of hereditary angioedema or idiopathic angioedema. <br/ >15. Any history of anaphylaxis in relation to vaccination. <br/ >16. Any history of albumin-intolerance. <br/ >17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ >18. History of any cancer. <br/ >19. History of psychiatric severe conditions likely to affect participation in the study. <br/ >20. 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/ >21. Any other serious chronic illness requiring hospital specialist supervision. <br/ >22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ >23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ >24. Morbidly obese (BMI�35 kg/m2) or underweight (BMI �18 kg/m2). <br/ >25. Living in the same household of any COVID-19 positive person. <br/ >26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights

Phase 1: <br/ >1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ >or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ >(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ >care provider for follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ >4. Health care workers. <br/ >5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ >6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ >such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ >7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ >8. 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/ >9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ >10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ >11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ >12. 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/ >13. 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/ >14. Any history of hereditary angioedema or idiopathic angioedema. <br/ >15. Any history of anaphylaxis in relation to vaccination. <br/ >16. Any history of albumin-intolerance. <br/ >17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ >18. History of any cancer. <br/ >19. History of psychiatric severe conditions likely to affect participation in the study. <br/ >20. 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/ >21. Any other serious chronic illness requiring hospital specialist supervision. <br/ >22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ >23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ >24. Morbidly obese (BMI�35 kg/m2) or underweight (BMI �18 kg/m2). <br/ >25. Living in the same household of any COVID-19 positive person. <br/ >26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights