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

• Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment • Volunteer who is not literate. • Planned receipt of any vaccine other than the study intervention within 30 days before or after study vaccination. • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). • Planned or ongoing participation in any other interventional studies (of licensed or investigational products) =30 days before enrolment and for the duration of the study. • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Any history of hereditary or idiopathic angioedema. • Pregnancy, lactation or willingness/intention to become pregnant during the study. • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). • History of serious psychiatric condition likely to affect participation in the study. • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. • Any other serious chronic illness requiring hospital specialist supervision. • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week (e.g. more than 2 bottles of 500mls Tusker (beer) a day, more than 2 large glasses of 12% wine per day)

• Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment • Volunteer who is not literate. • Planned receipt of any vaccine other than the study intervention within 30 days before or after study vaccination. • Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). • Planned or ongoing participation in any other interventional studies (of licensed or investigational products) =30 days before enrolment and for the duration of the study. • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate. • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, recurrent severe infections and chronic use (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Any history of hereditary or idiopathic angioedema. • Pregnancy, lactation or willingness/intention to become pregnant during the study. • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). • History of serious psychiatric condition likely to affect participation in the study. • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture. • Any other serious chronic illness requiring hospital specialist supervision. • Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week (e.g. more than 2 bottles of 500mls Tusker (beer) a day, more than 2 large glasses of 12% wine per day)