Created at Source Raw Value Validated value
March 31, 2021, 4:03 p.m. oms

1. Those who do not meet the health standards in the comprehensive physical examination mainly include: (1) Patients with abnormal vital signs and clinical significance (awake pulse < 50 beats / min or > 100 beats / min, systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg), (2) Body mass index (BMI) < 18 kg / m2 or > 30 kg / m2, (3) 2 times of the upper or lower limit of the normal reference range, and the clinical significance was judged by the researchers. 2. Women who are in menstrual period (day 1-4) or lactation period, or women who plan to get pregnant within 12 months from screening period to full immunization, men who plan to get pregnant with their partners, or those who plan to donate sperm and eggs, 3. subjects with a history of New Coronavirus vaccination, 4. there were cases of suspected cases of New Coronavirus pneumonia and suspected cases, and 1 months before signing the informed consent. There were people who had contact with COVID-19 cases and suspected cases, or those with high incidence or overseas travel experience, or those with COVID-19 infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or SARS-CoV-2 nucleic acid positive in throat swabs. 5. Patients with positive etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), syphilis or HIV, 6. Patients with previous history of SARS, mers and other coronavirus infection or diseases, 7. Patients with acute disease or acute attack of chronic disease within 2 weeks before the first dose of vaccine, or with fever (axillary temperature > 37.3 degrees C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 8. Subjects with any history of severe adverse reactions of vaccine or drug, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 9. Subjects who had received any vaccine within one month before the first dose of vaccine, 10. Patients who can't tolerate venipuncture and have a history of needle and blood sickness, 11. Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 12. Patients who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 13. Subjects without spleen, functional spleen, and other important organs removed for any reason, 14. Patients with previous severe diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 15. Patients who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period or within 3 months after the end of the trial, 16. Subjects who donated or lost blood (>= 450 ml) within 3 months before signing the informed consent, who received blood transfusion or used blood products, or planned to donate blood during the trial, 17. Any research or unregistered products (drugs, vaccines, biological products or devices) other than the research vaccine were used or planned to be used during t

1. Those who do not meet the health standards in the comprehensive physical examination mainly include: (1) Patients with abnormal vital signs and clinical significance (awake pulse < 50 beats / min or > 100 beats / min, systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg), (2) Body mass index (BMI) < 18 kg / m2 or > 30 kg / m2, (3) 2 times of the upper or lower limit of the normal reference range, and the clinical significance was judged by the researchers. 2. Women who are in menstrual period (day 1-4) or lactation period, or women who plan to get pregnant within 12 months from screening period to full immunization, men who plan to get pregnant with their partners, or those who plan to donate sperm and eggs, 3. subjects with a history of New Coronavirus vaccination, 4. there were cases of suspected cases of New Coronavirus pneumonia and suspected cases, and 1 months before signing the informed consent. There were people who had contact with COVID-19 cases and suspected cases, or those with high incidence or overseas travel experience, or those with COVID-19 infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or SARS-CoV-2 nucleic acid positive in throat swabs. 5. Patients with positive etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), syphilis or HIV, 6. Patients with previous history of SARS, mers and other coronavirus infection or diseases, 7. Patients with acute disease or acute attack of chronic disease within 2 weeks before the first dose of vaccine, or with fever (axillary temperature > 37.3 degrees C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 8. Subjects with any history of severe adverse reactions of vaccine or drug, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 9. Subjects who had received any vaccine within one month before the first dose of vaccine, 10. Patients who can't tolerate venipuncture and have a history of needle and blood sickness, 11. Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 12. Patients who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 13. Subjects without spleen, functional spleen, and other important organs removed for any reason, 14. Patients with previous severe diseases with abnormal clinical manifestations that need to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 15. Patients who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period or within 3 months after the end of the trial, 16. Subjects who donated or lost blood (>= 450 ml) within 3 months before signing the informed consent, who received blood transfusion or used blood products, or planned to donate blood during the trial, 17. Any research or unregistered products (drugs, vaccines, biological products or devices) other than the research vaccine were used or planned to be used during t

Jan. 15, 2021, 12:45 a.m. oms

1. Subjects who do not meet the health standards as assessed through comprehensive physical examination, mainly including: (1) With abnormal and clinically significant vital signs (pulse rate under conscious state < 50 beats/min or > 100 beats/min, systolic blood pressure < 140 mmHg or diastolic blood pressure < 90 mmHg), (2) Body mass index (BMI) < 18 kg/m2 or > 30 kg/m2, (3) With laboratory values exceeding the upper or lower limit of normal reference range by 1.2 times during the screening time window and are adjudicated to be clinically significant by the investigators, 2. Females who are on period(day 1 to day 4 of period), males whose spouse plans to conceive, males or females who plan to donate sperm or eggs,who plan to conceive within 12 months from the screening period to completion of immunizations, 3. Subjects with history of SARA-CoV-2 vaccine vaccination, 4. Subjects who have been diagnosed as confirmed or suspected cases of COVID-19 pneumonia, who have contact with confirmed or suspected cases of COVID-19 within 1 month before signing the informed consent form, or who have traveled abroad or in areas with high epidemic incidence, or who are infected with COVID-19 or are COVID-19 carriers: positive for serum anti-SARS-CoV-2 specific antibody, or positive for SARS-CoV-2 nucleic acid in throat swab specimens, 5. Positive results of etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), sypilis or HIV, 6. With prior history of human coronavirus infection or disease such as SARS and MERS, 7. Subjects who develop acute diseases or are in acute attack of chronic diseases within 2 weeks before the first dose of investigational vaccine, or who have fever (axillary temperature>=37.3 degree C) or upper respiratory tract infection within 7 days before the first dose of investigational vaccine, 8. With any history of serious side effects due to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 9. Have received any vaccine within 1 month before the first dose of investigational vaccine, 10. Subjects who cannot tolerate venipuncture, or have a history of needle or blood phobia, 11. With inherited bleeding tendency or coagulation dysfunction, or have a history of thrombosis or hemorrhagic disease, and have abnormal findings of coagulation function related indicators, 12. Have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 13. Asplenia, functional asplenia, or have had surgical removal of other important organs for any reason, 14. With prior abnormal clinical manifestations and serious diseases that preclude the subjects from participating in the study, including but not limited to disorders of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumors (excluding patients with history of well-controlled chronic disease, such as diabetes, hypertension, etc.), 15. Have undergone surgery within 3 months before signing the informed consent form, or plan to undergo surgery (including cosmetic, dental and oral surgery) during the trial or within 3 months after the end of the trial, 16. Have donated blood or blood loss (> 450 mL) within 3 months before signing the informed consent form, recipients of blood transfusion or users of blood products, or plan to donate blood during the tria

1. Subjects who do not meet the health standards as assessed through comprehensive physical examination, mainly including: (1) With abnormal and clinically significant vital signs (pulse rate under conscious state < 50 beats/min or > 100 beats/min, systolic blood pressure < 140 mmHg or diastolic blood pressure < 90 mmHg), (2) Body mass index (BMI) < 18 kg/m2 or > 30 kg/m2, (3) With laboratory values exceeding the upper or lower limit of normal reference range by 1.2 times during the screening time window and are adjudicated to be clinically significant by the investigators, 2. Females who are on period(day 1 to day 4 of period), males whose spouse plans to conceive, males or females who plan to donate sperm or eggs,who plan to conceive within 12 months from the screening period to completion of immunizations, 3. Subjects with history of SARA-CoV-2 vaccine vaccination, 4. Subjects who have been diagnosed as confirmed or suspected cases of COVID-19 pneumonia, who have contact with confirmed or suspected cases of COVID-19 within 1 month before signing the informed consent form, or who have traveled abroad or in areas with high epidemic incidence, or who are infected with COVID-19 or are COVID-19 carriers: positive for serum anti-SARS-CoV-2 specific antibody, or positive for SARS-CoV-2 nucleic acid in throat swab specimens, 5. Positive results of etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), sypilis or HIV, 6. With prior history of human coronavirus infection or disease such as SARS and MERS, 7. Subjects who develop acute diseases or are in acute attack of chronic diseases within 2 weeks before the first dose of investigational vaccine, or who have fever (axillary temperature>=37.3 degree C) or upper respiratory tract infection within 7 days before the first dose of investigational vaccine, 8. With any history of serious side effects due to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 9. Have received any vaccine within 1 month before the first dose of investigational vaccine, 10. Subjects who cannot tolerate venipuncture, or have a history of needle or blood phobia, 11. With inherited bleeding tendency or coagulation dysfunction, or have a history of thrombosis or hemorrhagic disease, and have abnormal findings of coagulation function related indicators, 12. Have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 13. Asplenia, functional asplenia, or have had surgical removal of other important organs for any reason, 14. With prior abnormal clinical manifestations and serious diseases that preclude the subjects from participating in the study, including but not limited to disorders of nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumors (excluding patients with history of well-controlled chronic disease, such as diabetes, hypertension, etc.), 15. Have undergone surgery within 3 months before signing the informed consent form, or plan to undergo surgery (including cosmetic, dental and oral surgery) during the trial or within 3 months after the end of the trial, 16. Have donated blood or blood loss (> 450 mL) within 3 months before signing the informed consent form, recipients of blood transfusion or users of blood products, or plan to donate blood during the tria