Created at Source Raw Value Validated value
Feb. 11, 2022, 8 a.m. oms

1. Abnormal vital sign or laboratory test prior to D0 judged as clinically significant by investigator. 2. Known allergic, hypersensitive, or intolerant to the test vaccine (including any excipients). 3. History of severe allergies to any drugs, foods or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc. 4. Diagnosed with any serious disease, or chronic disease, or congenital malformation, that may influence the compliance with the study including but not limited to respiratory disease such as asthma or chronic bronchitis, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergy, etc. 5. History or family history of convulsions, seizures, encephalopathy, and mental illness. 6. History of narcolepsy. 7. Known substance abuse and addiction through medical history. 8. Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0. 9. Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0. 10. Blood loss > 400 mL within 28 days prior to D0 (e.g., donated blood or blood products or injury), or planned to donate blood or plasma before D49 of the study. 11. Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0. 12. Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea. 13. Contraindications to intramuscular injection, such as thrombocytopenia, any clotting disorder, or treatment with anticoagulants. 14. Any abnormalities or permanent body art (such as tattoos) at the injection site that may influence the investigator to observe the local reactions of the injection site. 15. Received any vaccines within 28 days prior to D0 or disagree to avoid receiving any vaccines before D49 of

1. Abnormal vital sign or laboratory test prior to D0 judged as clinically significant by investigator. 2. Known allergic, hypersensitive, or intolerant to the test vaccine (including any excipients). 3. History of severe allergies to any drugs, foods or vaccines, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc. 4. Diagnosed with any serious disease, or chronic disease, or congenital malformation, that may influence the compliance with the study including but not limited to respiratory disease such as asthma or chronic bronchitis, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergy, etc. 5. History or family history of convulsions, seizures, encephalopathy, and mental illness. 6. History of narcolepsy. 7. Known substance abuse and addiction through medical history. 8. Uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to D0. 9. Use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to D0. 10. Blood loss > 400 mL within 28 days prior to D0 (e.g., donated blood or blood products or injury), or planned to donate blood or plasma before D49 of the study. 11. Use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to D0. 12. Have symptoms of COVID-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea. 13. Contraindications to intramuscular injection, such as thrombocytopenia, any clotting disorder, or treatment with anticoagulants. 14. Any abnormalities or permanent body art (such as tattoos) at the injection site that may influence the investigator to observe the local reactions of the injection site. 15. Received any vaccines within 28 days prior to D0 or disagree to avoid receiving any vaccines before D49 of