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

1. abnormal results of laboratory screening tests which was clinically significant judged by clinicians; 2. abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 mmhg, or axillary body temperature ≥ 37.3°c; 3. known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients; 4. history of human coronavirus infection/diseases, such as severe acute respiratory syndrome (sars) or middle east respiratory syndrome (mers); 5. history of covid-19, or history of close contact with confirmed/suspected covid-19 patients, or positive results for either sars-cov-2 nucleic acid or antibody tests (igg and igm) at screening; 6. administration of antipyretics or painkillers within 24 hours prior to vaccination; 7. receipt of any covid-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination; 8. receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period. 9. subjects with the following diseases: 1. any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment; 2. congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 3. congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids; 4. currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, human immunodeficiency virus antibody; 5. history or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders; 6. asplenia, or functional asplenia; 7. presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, neurological diseases (e.g., guillain-barre syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; 8. contraindications to im injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. 10. drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures; 11. history of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study; 12. pregnant or lactating females, or those who plan to become pregnant during the study period; 13. having participated or being participating in covid-19 related clinical trials, and those being participating or planning to participate in other clinical trials during the study period; 14. presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.

1. abnormal results of laboratory screening tests which was clinically significant judged by clinicians; 2. abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 mmhg, or axillary body temperature ≥ 37.3°c; 3. known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients; 4. history of human coronavirus infection/diseases, such as severe acute respiratory syndrome (sars) or middle east respiratory syndrome (mers); 5. history of covid-19, or history of close contact with confirmed/suspected covid-19 patients, or positive results for either sars-cov-2 nucleic acid or antibody tests (igg and igm) at screening; 6. administration of antipyretics or painkillers within 24 hours prior to vaccination; 7. receipt of any covid-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination; 8. receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period. 9. subjects with the following diseases: 1. any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment; 2. congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 3. congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids; 4. currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, human immunodeficiency virus antibody; 5. history or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders; 6. asplenia, or functional asplenia; 7. presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, neurological diseases (e.g., guillain-barre syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; 8. contraindications to im injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. 10. drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures; 11. history of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study; 12. pregnant or lactating females, or those who plan to become pregnant during the study period; 13. having participated or being participating in covid-19 related clinical trials, and those being participating or planning to participate in other clinical trials during the study period; 14. presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.

Nov. 19, 2021, 7:30 p.m. usa

abnormal results of laboratory screening tests which was clinically significant judged by clinicians; abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 mmhg, or axillary body temperature ≥ 37.3°c; known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients; history of human coronavirus infection/diseases, such as severe acute respiratory syndrome (sars) or middle east respiratory syndrome (mers); history of covid-19, or history of close contact with confirmed/suspected covid-19 patients, or positive results for either sars-cov-2 nucleic acid or antibody tests (igg and igm) at screening; administration of antipyretics or painkillers within 24 hours prior to vaccination; receipt of any covid-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination; receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period. subjects with the following diseases: any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment; congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids; currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, human immunodeficiency virus antibody; history or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders; asplenia, or functional asplenia; presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, neurological diseases (e.g., guillain-barre syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; contraindications to im injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures; history of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study; pregnant or lactating females, or those who plan to become pregnant during the study period; having participated or being participating in covid-19 related clinical trials, and those being participating or planning to participate in other clinical trials during the study period; presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.

abnormal results of laboratory screening tests which was clinically significant judged by clinicians; abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 mmhg, or axillary body temperature ≥ 37.3°c; known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients; history of human coronavirus infection/diseases, such as severe acute respiratory syndrome (sars) or middle east respiratory syndrome (mers); history of covid-19, or history of close contact with confirmed/suspected covid-19 patients, or positive results for either sars-cov-2 nucleic acid or antibody tests (igg and igm) at screening; administration of antipyretics or painkillers within 24 hours prior to vaccination; receipt of any covid-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination; receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period. subjects with the following diseases: any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment; congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids; currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, human immunodeficiency virus antibody; history or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders; asplenia, or functional asplenia; presence of severe, uncontrollable or hospitalization indicated cardiovascular diseases, diabetes, neurological diseases (e.g., guillain-barre syndrome), blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; contraindications to im injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures; history of a major surgery, per the investigator's judgment, within 12 weeks before vaccination, or not achieving full recovery after surgery, or any planned major surgery during the study; pregnant or lactating females, or those who plan to become pregnant during the study period; having participated or being participating in covid-19 related clinical trials, and those being participating or planning to participate in other clinical trials during the study period; presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response.