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

* known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines * history of severe acute respiratory syndrome (sars) and/or middle east respiratory syndrome (mers) or covid-19 infection or disease; * used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; * vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; * administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; * patients with the following diseases: 1. any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; 2. congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; 3. history of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously\>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; 4. positive for anti-aids antibody; 5. neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; 6. asplenia or functional asplenia; 7. serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; 8. contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; 9. severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmhg and/or diastolic blood pressure ≥100mmhg) . * history of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; * participating or will participate other clinical trials during this trial; * any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. * women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;

* known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines * history of severe acute respiratory syndrome (sars) and/or middle east respiratory syndrome (mers) or covid-19 infection or disease; * used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; * vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; * administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; * patients with the following diseases: 1. any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; 2. congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; 3. history of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously\>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; 4. positive for anti-aids antibody; 5. neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; 6. asplenia or functional asplenia; 7. serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; 8. contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; 9. severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmhg and/or diastolic blood pressure ≥100mmhg) . * history of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; * participating or will participate other clinical trials during this trial; * any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. * women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;

Dec. 24, 2022, 4 p.m. usa

known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines history of severe acute respiratory syndrome (sars) and/or middle east respiratory syndrome (mers) or covid-19 infection or disease; used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; patients with the following diseases: any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; history of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; positive for anti-aids antibody; neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; asplenia or functional asplenia; serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmhg and/or diastolic blood pressure ≥100mmhg) . history of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; participating or will participate other clinical trials during this trial; any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;

known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines history of severe acute respiratory syndrome (sars) and/or middle east respiratory syndrome (mers) or covid-19 infection or disease; used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment; vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment; administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use duringthe trial; patients with the following diseases: any acute disease or in the acute phase of chronic diseases within 7 days before enrollment; congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.; history of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids; positive for anti-aids antibody; neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history; asplenia or functional asplenia; serious or uncontrollable cardiovascular diseases, diabetes,hematological and lymphatic diseases, immune system diseases,liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization; contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant; severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmhg and/or diastolic blood pressure ≥100mmhg) . history of major surgery within 12 weeks before enrollment (judged by the investigator), or incomplete recovery after surgery, or planning major surgery during the trial; participating or will participate other clinical trials during this trial; any disease or condition that would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine. women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;