Created at Source Raw Value Validated value
June 2, 2022, 8 a.m. oms

1. A history of COVID-19 or the use of any COVID-19 preventive medicine other than the new coronavirus inactivated vaccine, 2. Abnormal blood pressure and pulse test results during the screening period (awake state pulse <50 beats/min or >100 beats/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) and clinical significance judged by the investigator, 3. Positive for SARS-CoV-2 etiological test (RT-PCR test), 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Fever (axillary temperature >=37.3 degree) on the day of vaccination and within the last 72 hours, 6. Women are breastfeeding, 7. Plan to become pregnant or plan to discontinue effective contraceptive measures within 6 months after vaccination with the experimental vaccine, 8. The clinical investigators and sponsor staff are specifically involved in this trial, 9. History of severe allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc., 10. Any vaccine within 28 days before the experimental vaccine, 11. Those who have participated in the clinical trials of other drugs within 28 days before vaccination or plan to participate in other drug clinical trials within 12 months after the vaccination, 12. Has hereditary bleeding tendency or abnormal coagulation function (such as: coagulation factor deficiency, coagulation disorder or thrombocytopenia), or has a history of severe bleeding, 13. Based on known medical history or diagnosis confirmed to have diseases that affect the function of the immune system, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency (eg: HIV infection), uncontrolled autoimmune diseases, After organ transplantation, etc., 14. Asplenia or functional asplenia, 15. Long-term use (continuous use >= 14 days) of immunosuppressive drugs or other immunomodulatory drugs (such as cortisol hormones: prednisone or similar drugs, interferon, etc.) within 6 months before the experimental vaccine, but topical use is allowed Medication (such as ointment, eye drops, inhaler, or nasal spray), and topical use should not exceed the dose recommended in the instructions, 16. Received immunoglobulin and/or blood products within 3 months before the experimental vaccine, 17. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or affect subject compliance, 18. Plan to permanently relocate from the region before the end of the study or to leave the region for a long time during the study visit, 19. Other factors deemed inappropriate by the investigator to participate in this trial.

1. A history of COVID-19 or the use of any COVID-19 preventive medicine other than the new coronavirus inactivated vaccine, 2. Abnormal blood pressure and pulse test results during the screening period (awake state pulse <50 beats/min or >100 beats/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) and clinical significance judged by the investigator, 3. Positive for SARS-CoV-2 etiological test (RT-PCR test), 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Fever (axillary temperature >=37.3 degree) on the day of vaccination and within the last 72 hours, 6. Women are breastfeeding, 7. Plan to become pregnant or plan to discontinue effective contraceptive measures within 6 months after vaccination with the experimental vaccine, 8. The clinical investigators and sponsor staff are specifically involved in this trial, 9. History of severe allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc., 10. Any vaccine within 28 days before the experimental vaccine, 11. Those who have participated in the clinical trials of other drugs within 28 days before vaccination or plan to participate in other drug clinical trials within 12 months after the vaccination, 12. Has hereditary bleeding tendency or abnormal coagulation function (such as: coagulation factor deficiency, coagulation disorder or thrombocytopenia), or has a history of severe bleeding, 13. Based on known medical history or diagnosis confirmed to have diseases that affect the function of the immune system, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency (eg: HIV infection), uncontrolled autoimmune diseases, After organ transplantation, etc., 14. Asplenia or functional asplenia, 15. Long-term use (continuous use >= 14 days) of immunosuppressive drugs or other immunomodulatory drugs (such as cortisol hormones: prednisone or similar drugs, interferon, etc.) within 6 months before the experimental vaccine, but topical use is allowed Medication (such as ointment, eye drops, inhaler, or nasal spray), and topical use should not exceed the dose recommended in the instructions, 16. Received immunoglobulin and/or blood products within 3 months before the experimental vaccine, 17. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or affect subject compliance, 18. Plan to permanently relocate from the region before the end of the study or to leave the region for a long time during the study visit, 19. Other factors deemed inappropriate by the investigator to participate in this trial.

Dec. 4, 2021, midnight oms

1. COVID-19 history or use of any COVID-19 preventive medicine other than New Coronavirus inactivated vaccine, 2. Abnormal blood pressure and pulse test results during screening (18 ~ 59 years old: awake pulse < 50 times / min or > 100 times / min, systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg, 60 years old and above: awake pulse < 50 times / min or > 100 times / min, systolic blood pressure >=150mmhg or diastolic blood pressure >= 90mmHg) and clinically significant according to the judgment of the researcher, 3. Sars-cov-2 etiology test (RT-PCR test) was positive, 4.Past history of SARS, MERS and other coronavirus infection or disease history. 5. Fever (axillary temperature >=37.3 degree C) on the day of vaccination and nearly 72 hours, 6. Women are in pregnancy (e.g. positive pregnancy test) or lactation, 7. Planned pregnancy or planned interruption of effective contraceptive measures within 6 months after vaccination, 8. The clinical researchers, sponsors and staff involved in the trial, 9. Previous history of severe allergic reaction or allergic reaction to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneuroedema, etc., 10. Inoculate any vaccine within 28 days before vaccination, 11. Have participated in clinical trials of other drugs within 28 days before vaccination or plan to participate in clinical trials of other drugs within 12 months after immunization, 12. Have hereditary bleeding tendency or abnormal coagulation function (e.g. coagulation factor defect, coagulation disorder or thrombocytopenia), or have a history of severe bleeding, 13. According to the known medical history or diagnosis, it is confirmed that it has diseases affecting the function of the immune system, such as cancer (except skin basal cell carcinoma), congenital or acquired immune deficiency (such as HIV infection), uncontrollable autoimmune diseases, post organ transplantation, etc, 14. No spleen or functional no spleen, 15. Long term use (continuous use >= 14 days) of immunosuppressants or other immunomodulatory drugs (such as cortisol hormone: prednisone or similar drugs, interferon, etc.) within 6 months before vaccination, but local medication (such as ointment, eye drops, inhalants or nasal spray) is allowed, and the local medication shall not exceed the dose recommended in the instructions, 16. Received immunoglobulin and / or blood products within 3 months before vaccination, 17. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or subject compliance, 18. Plan to permanently relocate from the region before the end of the study or leave the region for a long time during the study visit, 19. Other factors that the researcher believes are not suitable to participate in this experiment.

1. COVID-19 history or use of any COVID-19 preventive medicine other than New Coronavirus inactivated vaccine, 2. Abnormal blood pressure and pulse test results during screening (18 ~ 59 years old: awake pulse < 50 times / min or > 100 times / min, systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg, 60 years old and above: awake pulse < 50 times / min or > 100 times / min, systolic blood pressure >=150mmhg or diastolic blood pressure >= 90mmHg) and clinically significant according to the judgment of the researcher, 3. Sars-cov-2 etiology test (RT-PCR test) was positive, 4.Past history of SARS, MERS and other coronavirus infection or disease history. 5. Fever (axillary temperature >=37.3 degree C) on the day of vaccination and nearly 72 hours, 6. Women are in pregnancy (e.g. positive pregnancy test) or lactation, 7. Planned pregnancy or planned interruption of effective contraceptive measures within 6 months after vaccination, 8. The clinical researchers, sponsors and staff involved in the trial, 9. Previous history of severe allergic reaction or allergic reaction to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneuroedema, etc., 10. Inoculate any vaccine within 28 days before vaccination, 11. Have participated in clinical trials of other drugs within 28 days before vaccination or plan to participate in clinical trials of other drugs within 12 months after immunization, 12. Have hereditary bleeding tendency or abnormal coagulation function (e.g. coagulation factor defect, coagulation disorder or thrombocytopenia), or have a history of severe bleeding, 13. According to the known medical history or diagnosis, it is confirmed that it has diseases affecting the function of the immune system, such as cancer (except skin basal cell carcinoma), congenital or acquired immune deficiency (such as HIV infection), uncontrollable autoimmune diseases, post organ transplantation, etc, 14. No spleen or functional no spleen, 15. Long term use (continuous use >= 14 days) of immunosuppressants or other immunomodulatory drugs (such as cortisol hormone: prednisone or similar drugs, interferon, etc.) within 6 months before vaccination, but local medication (such as ointment, eye drops, inhalants or nasal spray) is allowed, and the local medication shall not exceed the dose recommended in the instructions, 16. Received immunoglobulin and / or blood products within 3 months before vaccination, 17. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or subject compliance, 18. Plan to permanently relocate from the region before the end of the study or leave the region for a long time during the study visit, 19. Other factors that the researcher believes are not suitable to participate in this experiment.