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

For Phase I <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibody and antigen against SARS-CoV-2. <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Any clinically significant laboratory or ECG findings during screening or check-in <br/ >8.History or presence of significant smoking (�10 cigarettes per day) <br/ >9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. <br/ >10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II <br/ > <br/ >For Phase II <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ >8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

For Phase I <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibody and antigen against SARS-CoV-2. <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Any clinically significant laboratory or ECG findings during screening or check-in <br/ >8.History or presence of significant smoking (�10 cigarettes per day) <br/ >9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. <br/ >10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II <br/ > <br/ >For Phase II <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ >8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

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

N/A

N/A

Oct. 26, 2020, 8:29 a.m. oms

For Phase I <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibody and antigen against SARS-CoV-2. <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Any clinically significant laboratory or ECG findings during screening or check-in <br/ >8.History or presence of significant smoking (�10 cigarettes per day) <br/ >9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. <br/ >10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II <br/ > <br/ >For Phase II <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ >8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

For Phase I <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibody and antigen against SARS-CoV-2. <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Any clinically significant laboratory or ECG findings during screening or check-in <br/ >8.History or presence of significant smoking (�10 cigarettes per day) <br/ >9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. <br/ >10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II <br/ > <br/ >For Phase II <br/ >1.Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2.History of confirmed SARS-CoV-2 positive <br/ >3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ >4.History of SARS/ MERS infection <br/ >5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening <br/ >6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ >7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ >8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy