Created at Source Raw Value Validated value
June 25, 2024, noon usa

* subject who met any of the following criteria may not be enrolled. 1. abnormal vital signs or laboratory test results prior to d0 judged as clinically significant by investigator. 2. known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides). 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 congenital malformation, or uncontrolled chronic disease 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 within the past 2 years. 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 d28 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. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. 14. surgical removal of whole or part of spleen for any reason 15. received any vaccines within 28 days prior to d0 or disagree to avoid receiving any vaccines before d28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine. 16. participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period. 17. any other conditions not eligible for participating in the study at investigator's discretion.

* subject who met any of the following criteria may not be enrolled. 1. abnormal vital signs or laboratory test results prior to d0 judged as clinically significant by investigator. 2. known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides). 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 congenital malformation, or uncontrolled chronic disease 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 within the past 2 years. 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 d28 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. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. 14. surgical removal of whole or part of spleen for any reason 15. received any vaccines within 28 days prior to d0 or disagree to avoid receiving any vaccines before d28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine. 16. participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period. 17. any other conditions not eligible for participating in the study at investigator's discretion.

July 20, 2022, noon usa

subject who met any of the following criteria may not be enrolled. abnormal vital signs or laboratory test results prior to d0 judged as clinically significant by investigator. known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides). 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. diagnosed with any serious disease, or congenital malformation, or uncontrolled chronic disease 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. history or family history of convulsions, seizures, encephalopathy, and mental illness. history of narcolepsy. known substance abuse and addiction within the past 2 years. uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to d0. use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to d0. 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 d28 of the study. use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to d0 have symptoms of covid-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. surgical removal of whole or part of spleen for any reason received any vaccines within 28 days prior to d0 or disagree to avoid receiving any vaccines before d28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine. participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period. any other conditions not eligible for participating in the study at investigator's discretion.

subject who met any of the following criteria may not be enrolled. abnormal vital signs or laboratory test results prior to d0 judged as clinically significant by investigator. known allergy, hypersensitivity, or intolerance to the test vaccine (including any excipients and the antibiotics kanamycin and aminoglycosides). 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. diagnosed with any serious disease, or congenital malformation, or uncontrolled chronic disease 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. history or family history of convulsions, seizures, encephalopathy, and mental illness. history of narcolepsy. known substance abuse and addiction within the past 2 years. uninterrupted use of systemic immunosuppressants or other immunomodulators within 30 days prior to d0. use of blood or blood-related products (e.g., blood transfusion, human albumin, human immunoglobulin, etc.) within 30 days prior to d0. 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 d28 of the study. use of nonsteroidal anti-inflammatory drugs and/or antiallergic drugs within 3 days prior to d0 have symptoms of covid-19, such as respiratory symptoms, fever, cough, shortness of breath and dyspnea. bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating im vaccination based on investigator's judgment. surgical removal of whole or part of spleen for any reason received any vaccines within 28 days prior to d0 or disagree to avoid receiving any vaccines before d28 of the study except the emergent vaccination such as rabies vaccine, tetanus vaccine. participating in or planning to participate in other clinical trials (drugs or vaccines) during the study period. any other conditions not eligible for participating in the study at investigator's discretion.