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. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ >or safety testing as listed below. <br/ >ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ >(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ >be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ >hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ >follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ >4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ >study <br/ >5. 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 3 days before <br/ >each dose of vaccine. <br/ >6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ >months. <br/ >7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ >before enrolment or expects to receive an experimental agent during the study <br/ >period. <br/ >8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ >allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ >in the past. <br/ >9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ >within the 3 months before vaccination in this study. <br/ >10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ >underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ >use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ >months. <br/ >11. 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 6 months (nasal and topical steroids are <br/ >allowed). <br/ >12. Any history of hereditary angioedema or idiopathic angioedema. <br/ >13. History of any cancer. <br/ >14. History of serious psychiatric conditions likely to affect participation in the <br/ >study. <br/ >15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ >or prior history of significant bleeding following venipuncture. <br/ >16. Any other serious chronic illness requiring hospital specialist supervision. <br/ >17. Chronic respiratory diseases (SARS), including mild asthma <br/ >18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ >disease, an endocrine disorder, and neurological illness <br/ >19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ >20. Living in the same household of any COVID-19 positive. <br/ >21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ >May 2020. Should a reliable test become available, these exclusion criteria will <br/ >be replaced with seropositivity for COVID-19 before enrolment. <br/ >22. Any other condition that in the opinion of the investigator would jeopardize the <br/ >safety or rights of a volunteer participating in the trial or would render th

1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ >or safety testing as listed below. <br/ >ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ >(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ >be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ >hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ >follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ >4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ >study <br/ >5. 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 3 days before <br/ >each dose of vaccine. <br/ >6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ >months. <br/ >7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ >before enrolment or expects to receive an experimental agent during the study <br/ >period. <br/ >8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ >allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ >in the past. <br/ >9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ >within the 3 months before vaccination in this study. <br/ >10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ >underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ >use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ >months. <br/ >11. 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 6 months (nasal and topical steroids are <br/ >allowed). <br/ >12. Any history of hereditary angioedema or idiopathic angioedema. <br/ >13. History of any cancer. <br/ >14. History of serious psychiatric conditions likely to affect participation in the <br/ >study. <br/ >15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ >or prior history of significant bleeding following venipuncture. <br/ >16. Any other serious chronic illness requiring hospital specialist supervision. <br/ >17. Chronic respiratory diseases (SARS), including mild asthma <br/ >18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ >disease, an endocrine disorder, and neurological illness <br/ >19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ >20. Living in the same household of any COVID-19 positive. <br/ >21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ >May 2020. Should a reliable test become available, these exclusion criteria will <br/ >be replaced with seropositivity for COVID-19 before enrolment. <br/ >22. Any other condition that in the opinion of the investigator would jeopardize the <br/ >safety or rights of a volunteer participating in the trial or would render th

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

N/A

N/A

Dec. 16, 2020, 10:47 a.m. oms

1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ >or safety testing as listed below. <br/ >ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ >(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ >be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ >hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ >follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ >4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ >study <br/ >5. 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 3 days before <br/ >each dose of vaccine. <br/ >6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ >months. <br/ >7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ >before enrolment or expects to receive an experimental agent during the study <br/ >period. <br/ >8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ >allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ >in the past. <br/ >9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ >within the 3 months before vaccination in this study. <br/ >10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ >underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ >use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ >months. <br/ >11. 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 6 months (nasal and topical steroids are <br/ >allowed). <br/ >12. Any history of hereditary angioedema or idiopathic angioedema. <br/ >13. History of any cancer. <br/ >14. History of serious psychiatric conditions likely to affect participation in the <br/ >study. <br/ >15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ >or prior history of significant bleeding following venipuncture. <br/ >16. Any other serious chronic illness requiring hospital specialist supervision. <br/ >17. Chronic respiratory diseases (SARS), including mild asthma <br/ >18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ >disease, an endocrine disorder, and neurological illness <br/ >19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ >20. Living in the same household of any COVID-19 positive. <br/ >21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ >May 2020. Should a reliable test become available, these exclusion criteria will <br/ >be replaced with seropositivity for COVID-19 before enrolment. <br/ >22. Any other condition that in the opinion of the investigator would jeopardize the <br/ >safety or rights of a volunteer participating in the trial or would render th

1. History of any other COVID-19 investigational vaccination. <br/ >2. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ >or safety testing as listed below. <br/ >ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ >(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ >be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ >hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ >follow up of these abnormal laboratory tests.) <br/ >3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ >4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ >study <br/ >5. 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 3 days before <br/ >each dose of vaccine. <br/ >6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ >months. <br/ >7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ >before enrolment or expects to receive an experimental agent during the study <br/ >period. <br/ >8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ >allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ >in the past. <br/ >9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ >within the 3 months before vaccination in this study. <br/ >10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ >underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ >use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ >months. <br/ >11. 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 6 months (nasal and topical steroids are <br/ >allowed). <br/ >12. Any history of hereditary angioedema or idiopathic angioedema. <br/ >13. History of any cancer. <br/ >14. History of serious psychiatric conditions likely to affect participation in the <br/ >study. <br/ >15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ >or prior history of significant bleeding following venipuncture. <br/ >16. Any other serious chronic illness requiring hospital specialist supervision. <br/ >17. Chronic respiratory diseases (SARS), including mild asthma <br/ >18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ >disease, an endocrine disorder, and neurological illness <br/ >19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ >20. Living in the same household of any COVID-19 positive. <br/ >21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ >May 2020. Should a reliable test become available, these exclusion criteria will <br/ >be replaced with seropositivity for COVID-19 before enrolment. <br/ >22. Any other condition that in the opinion of the investigator would jeopardize the <br/ >safety or rights of a volunteer participating in the trial or would render th