Created at Source Raw Value Validated value
March 29, 2022, 12:06 p.m. oms

1. The results of physical examination and laboratory examination before screening are abnormal and clinically significant as determined by the clinician, 2. History of severe allergy to any component of the trial vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc., or have a history of the above-mentioned serious side effects after using any vaccines or drugs in the past, 3. Those with a history of SARS and SARS-CoV-2 (meet any of the following: (1) Have a history of SARS and SARS-CoV-2 infection or disease in the past, (2) During the current SRAS-CoV-2 epidemic, there is a history of contact with confirmed/suspected patients of the new crown, (3) Detection of SARS-CoV-2 IgM and/or IgG antibody positive, (4) Real-time fluorescent RT-PCR nucleic acid positive,), 4. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination, 5. Those who have been vaccinated against the new coronavirus, or subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and live attenuated vaccine within 30 days, 6. Those suffering from the following diseases: (1) Acute (within 72 hours) febrile illness (aged >14 years, armpit temperature >=37.3?, aged <=14 years, armpit temperature >=37.5?), (2) Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days, (3) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., (4) History of congenital or acquired immunodeficiency or autoimmune disease or receiving immunomodulatory treatment within 6 months, such as immunosuppressive dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than a week), or monoclonal antibody, or thymosin, or interferon, (5) Known to be diagnosed with infectious diseases, such as: active tuberculosis, viral hepatitis patients and/or human immunodeficiency virus HIV antibody positive or syphilis-specific antibody positive or parents are HIV-infected, (6) Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy, stroke, seizure within the last three years, encephalopathy, focal neurological deficit, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis), psychiatric or family history, (7) Functional asplenia, as well as asplenia or splenectomy due to any cause, (8) Patients with serious chronic diseases or in advanced stages that cannot be controlled smoothly, such as diabetes and thyroid diseases, (9) Severe liver and kidney disease, current respiratory disease requiring daily drug treatment (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory disease (eg, asthma exacerbation) within the past 5 years, a history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis, (10) Thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc., (11) Cancer patients, 7. Received blood or blood-related products, including immune globulin, within 3 months, or planned to use it during the study, 8. Those who are pregnant (including positive urine pregnancy test), or are breastf

1. The results of physical examination and laboratory examination before screening are abnormal and clinically significant as determined by the clinician, 2. History of severe allergy to any component of the trial vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc., or have a history of the above-mentioned serious side effects after using any vaccines or drugs in the past, 3. Those with a history of SARS and SARS-CoV-2 (meet any of the following: (1) Have a history of SARS and SARS-CoV-2 infection or disease in the past, (2) During the current SRAS-CoV-2 epidemic, there is a history of contact with confirmed/suspected patients of the new crown, (3) Detection of SARS-CoV-2 IgM and/or IgG antibody positive, (4) Real-time fluorescent RT-PCR nucleic acid positive,), 4. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination, 5. Those who have been vaccinated against the new coronavirus, or subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and live attenuated vaccine within 30 days, 6. Those suffering from the following diseases: (1) Acute (within 72 hours) febrile illness (aged >14 years, armpit temperature >=37.3?, aged <=14 years, armpit temperature >=37.5?), (2) Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days, (3) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., (4) History of congenital or acquired immunodeficiency or autoimmune disease or receiving immunomodulatory treatment within 6 months, such as immunosuppressive dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than a week), or monoclonal antibody, or thymosin, or interferon, (5) Known to be diagnosed with infectious diseases, such as: active tuberculosis, viral hepatitis patients and/or human immunodeficiency virus HIV antibody positive or syphilis-specific antibody positive or parents are HIV-infected, (6) Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy, stroke, seizure within the last three years, encephalopathy, focal neurological deficit, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis), psychiatric or family history, (7) Functional asplenia, as well as asplenia or splenectomy due to any cause, (8) Patients with serious chronic diseases or in advanced stages that cannot be controlled smoothly, such as diabetes and thyroid diseases, (9) Severe liver and kidney disease, current respiratory disease requiring daily drug treatment (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory disease (eg, asthma exacerbation) within the past 5 years, a history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis, (10) Thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc., (11) Cancer patients, 7. Received blood or blood-related products, including immune globulin, within 3 months, or planned to use it during the study, 8. Those who are pregnant (including positive urine pregnancy test), or are breastf

July 16, 2021, 2 p.m. oms

1) The results of physical examination and laboratory examination before screening were abnormal and clinically significant, 2) Any component of the test vaccine, including aluminum preparation, has a history of severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc, Or the above-mentioned serious adverse reactions occurred after the use of any vaccine or drug in the past, 3) patients with history of SARS and SARS-CoV-2 (meet any of the following items: (1) history of infection or history of SARS and SARS-CoV-2, ? During the epidemic of sras-cov-2, there was a history of contact with patients diagnosed / suspected with new crown, ? The detection of sars-cov-2 IgM and / or IgG antibody was positive, ? RT-PCR was positive, 4) They had taken antipyretics or analgesics within 24 hours before the first dose of vaccine, 5) those who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 30 days within 14 days before the first dose of the vaccine are inoculated with the subunit vaccine and / or inactivated vaccine. 6) Patients with the following diseases: ? Patients with acute (within 72 hours) febrile diseases (> 14 years old, axillary temperature = 37.3 ?), 5 ?), ? Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days, ? Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc, ? A history of congenital or acquired immunodeficiency or autoimmune disease or immunomodulatory therapy within 6 months, such as immunosuppressive dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one week), Or monoclonal antibody, Or thymosin, Or interferon, etc, However, local medication (such as ointment, eye drops, inhaler or nasal spray) is allowed, ? known to be diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis, present or / or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive, or parents who are HIV infected, ? Neurological diseases or neurodevelopmental disorders (e.g., migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis), History of mental illness or family history, ? Functional asplenia and splenectomy for any reason, ?There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, thyroid disease, ? Severe liver and kidney diseases, Current respiratory diseases requiring daily medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (e.g., asthma exacerbation) in the last five years, A history of severe cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease), or myocarditis or pericarditis, ? Thrombocytopenia, any coagulation dysfunction or anticoagulant therapy, etc, ?Cancer patients, 7) Received blood or blood related products, including immunoglobulin, within 3 months, Or planned use during the study period, 8) Have been pregnant (including positive urine pregnancy test), or in lactation, 9) Use any researc

1) The results of physical examination and laboratory examination before screening were abnormal and clinically significant, 2) Any component of the test vaccine, including aluminum preparation, has a history of severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc, Or the above-mentioned serious adverse reactions occurred after the use of any vaccine or drug in the past, 3) patients with history of SARS and SARS-CoV-2 (meet any of the following items: (1) history of infection or history of SARS and SARS-CoV-2, ? During the epidemic of sras-cov-2, there was a history of contact with patients diagnosed / suspected with new crown, ? The detection of sars-cov-2 IgM and / or IgG antibody was positive, ? RT-PCR was positive, 4) They had taken antipyretics or analgesics within 24 hours before the first dose of vaccine, 5) those who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 30 days within 14 days before the first dose of the vaccine are inoculated with the subunit vaccine and / or inactivated vaccine. 6) Patients with the following diseases: ? Patients with acute (within 72 hours) febrile diseases (> 14 years old, axillary temperature = 37.3 ?), 5 ?), ? Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days, ? Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc, ? A history of congenital or acquired immunodeficiency or autoimmune disease or immunomodulatory therapy within 6 months, such as immunosuppressive dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one week), Or monoclonal antibody, Or thymosin, Or interferon, etc, However, local medication (such as ointment, eye drops, inhaler or nasal spray) is allowed, ? known to be diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis, present or / or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive, or parents who are HIV infected, ? Neurological diseases or neurodevelopmental disorders (e.g., migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis), History of mental illness or family history, ? Functional asplenia and splenectomy for any reason, ?There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, thyroid disease, ? Severe liver and kidney diseases, Current respiratory diseases requiring daily medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (e.g., asthma exacerbation) in the last five years, A history of severe cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease), or myocarditis or pericarditis, ? Thrombocytopenia, any coagulation dysfunction or anticoagulant therapy, etc, ?Cancer patients, 7) Received blood or blood related products, including immunoglobulin, within 3 months, Or planned use during the study period, 8) Have been pregnant (including positive urine pregnancy test), or in lactation, 9) Use any researc