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

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2. History or laboratory evidence 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. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ >5. History of SARS/ MERS infection <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 <br/ >9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ >11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ >12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ >13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ >14. Participation in another clinical trial in the past 3 months <br/ >15. History of drug / alcohol abuse <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 or laboratory evidence 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. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ >5. History of SARS/ MERS infection <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 <br/ >9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ >11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ >12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ >13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ >14. Participation in another clinical trial in the past 3 months <br/ >15. History of drug / alcohol abuse <br/ >

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

N/A

N/A

March 26, 2021, 2:21 p.m. oms

1. Febrile illness (temperature � 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ >2. History or laboratory evidence 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. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ >5. History of SARS/ MERS infection <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 <br/ >9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ >11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ >12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ >13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ >14. Participation in another clinical trial in the past 3 months <br/ >15. History of drug / alcohol abuse <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 or laboratory evidence 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. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ >5. History of SARS/ MERS infection <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 <br/ >9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder, or subjects on any immunosuppressive or immunostimulant therapy <br/ >10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ >11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ >12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ >13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ >14. Participation in another clinical trial in the past 3 months <br/ >15. History of drug / alcohol abuse <br/ >