Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

1. Pregnant or lactating 2. Presence of active systemic disease or pre-exisiting conditions that require investigation or a change to treatment that in the opinion of the investigator may compromise the volunteer’s safety, preclude vaccination or compromise interpretation of the immune response to vaccine 3. History of COVID-19 infection 4. History of severe or multiple allergies to drugs or pharmaceutical agents 5. History of severe local or general reaction to vaccination defined as: 5.1. Local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 5.2. General: fever >= 39.5oC within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 72 hours 6. Ever received an experimental vaccine against COVID-19 7. Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 8. Detection of antibodies to hepatitis C 9. Detection of antibodies to HIV 10. Grade 1 and above abnormalities in routine laboratory parameters (see Table 4) using the FDA toxicity table Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download) 11. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening 12. Has received an immunisation within 28 days of screening

1. Pregnant or lactating 2. Presence of active systemic disease or pre-exisiting conditions that require investigation or a change to treatment that in the opinion of the investigator may compromise the volunteer’s safety, preclude vaccination or compromise interpretation of the immune response to vaccine 3. History of COVID-19 infection 4. History of severe or multiple allergies to drugs or pharmaceutical agents 5. History of severe local or general reaction to vaccination defined as: 5.1. Local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 5.2. General: fever >= 39.5oC within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 72 hours 6. Ever received an experimental vaccine against COVID-19 7. Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 8. Detection of antibodies to hepatitis C 9. Detection of antibodies to HIV 10. Grade 1 and above abnormalities in routine laboratory parameters (see Table 4) using the FDA toxicity table Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (https://www.fda.gov/media/73679/download) 11. Participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening 12. Has received an immunisation within 28 days of screening