Created at Source Raw Value Validated value
Oct. 9, 2021, 9:30 a.m. eu

1. Has previously received any investigational or licensed COVID‐19 vaccine. 2. Has known congenital or acquired immune disorder or immunodeficiency that may interfere with vaccine response e.g. known infection with human immunodeficiency virus (HIV) with low CD4 count or other immunosuppression at time of signing informed consent form. 3. Has a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention (including systemic glucocorticoids), or findings that may have a significant effect on the target endpoints and which may therefore mask or inhibit the therapeutic effect under investigation as judged by the investigator. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6. Receipt of medications intended to prevent COVID‐19. 7. Uses drugs with significant interaction with the investigational product or has any contraindications as per the Summary of Product Characteristics. 8. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. 9. Has any kind of dependency on the principal investigator or member of the study team or is employed by the sponsor or principal investigator. 10. Is unable to report solicited adverse events.

1. Has previously received any investigational or licensed COVID‐19 vaccine. 2. Has known congenital or acquired immune disorder or immunodeficiency that may interfere with vaccine response e.g. known infection with human immunodeficiency virus (HIV) with low CD4 count or other immunosuppression at time of signing informed consent form. 3. Has a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention (including systemic glucocorticoids), or findings that may have a significant effect on the target endpoints and which may therefore mask or inhibit the therapeutic effect under investigation as judged by the investigator. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 6. Receipt of medications intended to prevent COVID‐19. 7. Uses drugs with significant interaction with the investigational product or has any contraindications as per the Summary of Product Characteristics. 8. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. 9. Has any kind of dependency on the principal investigator or member of the study team or is employed by the sponsor or principal investigator. 10. Is unable to report solicited adverse events.