Created at Source Raw Value Validated value
Jan. 30, 2021, 12:45 a.m. oms

Subjects meeting any of the following exclusion criteria were not included in the study 1. The subjects who did not meet the health standards in the comprehensive physical examination mainly included: (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 with positive pregnancy test (those with menstrual period or amenorrhea for at least one year or surgical sterilization with medical records can be exempted from pregnancy test), or women in lactation period, or women planning to get pregnant within 12 months from screening period to full immunization, men planning to get pregnant with their partners, or those planning to donate sperm and eggs, 3. Female subjects in menstrual period (from the first day to the fourth day of menstruation) on the day of vaccination, 4. With novel coronavirus vaccination history, 5. Suspected cases of novel coronavirus pneumonia and suspected cases were found. There was a history of contact with new crown virus cases and suspected cases within 1 months prior to the signing of informed consent, or those with high incidence or overseas travel experience. Or new crown virus infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or throat swab samples SARS-CoV-2 nucleic acid positive. 6. Subjects with positive HBsAg, HCV core antigen, HCV antibody, Treponema pallidum specific antibody and HIV antibody, 7. Subjects with previous history of SARS, mers and other coronavirus infection or diseases, 8. The subjects who developed acute diseases within 2 weeks before the first dose of vaccine or were in the stage of acute attack of chronic diseases, or had fever (axillary temperature >= 37.3 degee C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 9. Subjects with any history of severe side effects of vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 10. Objects who have received any vaccine within one month before the first dose of vaccine, 11. Those who can't tolerate venipuncture and have a history of needle and blood sickness, 12. Subjects with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 13. Persons who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 14. Subjects without spleen or functional spleen, and other important organs removed for any reason, 15. The objects with abnormal clinical manifestations and serious diseases that need to be excluded include but are not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 16. Subjects who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery during the trial or within 3 months after the trial (including cosmetic surgery, dental surgery and oral surgery), 17. The s

Subjects meeting any of the following exclusion criteria were not included in the study 1. The subjects who did not meet the health standards in the comprehensive physical examination mainly included: (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 with positive pregnancy test (those with menstrual period or amenorrhea for at least one year or surgical sterilization with medical records can be exempted from pregnancy test), or women in lactation period, or women planning to get pregnant within 12 months from screening period to full immunization, men planning to get pregnant with their partners, or those planning to donate sperm and eggs, 3. Female subjects in menstrual period (from the first day to the fourth day of menstruation) on the day of vaccination, 4. With novel coronavirus vaccination history, 5. Suspected cases of novel coronavirus pneumonia and suspected cases were found. There was a history of contact with new crown virus cases and suspected cases within 1 months prior to the signing of informed consent, or those with high incidence or overseas travel experience. Or new crown virus infection or carriers: Serum Anti SARS-CoV-2 specific antibody positive or throat swab samples SARS-CoV-2 nucleic acid positive. 6. Subjects with positive HBsAg, HCV core antigen, HCV antibody, Treponema pallidum specific antibody and HIV antibody, 7. Subjects with previous history of SARS, mers and other coronavirus infection or diseases, 8. The subjects who developed acute diseases within 2 weeks before the first dose of vaccine or were in the stage of acute attack of chronic diseases, or had fever (axillary temperature >= 37.3 degee C) or upper respiratory tract infection within 7 days before the first dose of vaccine, 9. Subjects with any history of severe side effects of vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 10. Objects who have received any vaccine within one month before the first dose of vaccine, 11. Those who can't tolerate venipuncture and have a history of needle and blood sickness, 12. Subjects with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators, 13. Persons who have been diagnosed with congenital or acquired immunodeficiency (e.g. HIV infection), 14. Subjects without spleen or functional spleen, and other important organs removed for any reason, 15. The objects with abnormal clinical manifestations and serious diseases that need to be excluded include but are not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolic and skeletal diseases and history of malignant tumor (excluding chronic disease with stable control, such as diabetes, hypertension, etc.), 16. Subjects who had undergone surgery within 3 months before signing the informed consent, or planned to undergo surgery during the trial or within 3 months after the trial (including cosmetic surgery, dental surgery and oral surgery), 17. The s

Nov. 12, 2020, 11:45 p.m. oms

Subjects who meet any of the following exclusion criteria may not be enrolled: 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. Women with positive pregnancy test (which may be exempt for women in menstrual phase or with amenorrhea for at least 1 year or who have medical records of surgical sterilization), or in lactation period, or who plan to conceive within 12 months from the screening period to completion of immunizations, 3. males whose spouse plans to conceive, males or females who plan to donate sperm or eggs,3.Females who are on period(day 1 to day 4 of period), 4. Subjects with history of SARA-CoV-2 vaccine vaccination, 5. 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, 6. Positive results of etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), sypilis or HIV, 7. With prior history of human coronavirus infection or disease such as SARS and MERS, 8. 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, 9. With any history of serious side effects due to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 10. Have received any vaccine within 1 month before the first dose of investigational vaccine, 11. Subjects who cannot tolerate venipuncture, or have a history of needle or blood phobia, 12. 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, 13. Have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 14. Asplenia, functional asplenia, or have had surgical removal of other important organs for any reason, 15. 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.), 16. Have undergone surgery within 3 months before signing the informed consent form, or plan to undergo surgery (including cosmet

Subjects who meet any of the following exclusion criteria may not be enrolled: 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. Women with positive pregnancy test (which may be exempt for women in menstrual phase or with amenorrhea for at least 1 year or who have medical records of surgical sterilization), or in lactation period, or who plan to conceive within 12 months from the screening period to completion of immunizations, 3. males whose spouse plans to conceive, males or females who plan to donate sperm or eggs,3.Females who are on period(day 1 to day 4 of period), 4. Subjects with history of SARA-CoV-2 vaccine vaccination, 5. 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, 6. Positive results of etiological or serological tests for hepatitis B (HBV), hepatitis C (HCV), sypilis or HIV, 7. With prior history of human coronavirus infection or disease such as SARS and MERS, 8. 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, 9. With any history of serious side effects due to vaccines or drugs, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc., 10. Have received any vaccine within 1 month before the first dose of investigational vaccine, 11. Subjects who cannot tolerate venipuncture, or have a history of needle or blood phobia, 12. 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, 13. Have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 14. Asplenia, functional asplenia, or have had surgical removal of other important organs for any reason, 15. 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.), 16. Have undergone surgery within 3 months before signing the informed consent form, or plan to undergo surgery (including cosmet