Created at Source Raw Value Validated value
Jan. 15, 2021, 12:45 a.m. oms

1. Novel coronavirus infection confirmed cases, 2. History of SARS and mers infection (self report, on-site inquiry), 3. Fever (axillary temperature > 37.0 degrees C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before inoculation, 4. The axillary temperature was more than 37.0 degrees C before inoculation, 5. Novel coronavirus inactivated vaccine has been sensitization to severe allergic reactions (such as acute allergic reaction, urticaria, eczema, dyspnea, neurovascular edema or abdominal pain). 6. History of convulsion, epilepsy, encephalopathy or mental illness or family history, 7. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc, 8. Severe liver and kidney diseases, drug uncontrollable hypertension (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg), diabetic complications, malignant tumor, acute attack of various acute or chronic diseases, 9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10. Known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors, 11. History of coagulation dysfunction (such as coagulation factor deficiency, coagulation diseases), 12. Receiving anti TB treatment, 13. Those who received immunoenhancement or immunosuppressive therapy within 3 months (continued oral or drip for more than 14 days), 14. Vaccinated with live attenuated vaccine within one month before vaccination and other vaccines within 14 days before vaccination, 15. Received blood products within 3 months before vaccination, 16. Received other research drugs within 6 months before vaccination, 17. The researcher judged other situations not suitable to participate in this clinical trial, 18. Severe allergic reaction and high fever (axillary temperature >= 39.0 degrees C) lasting for three days after the previous dose of vaccination, 19. Serious adverse reactions related to the previous dose of vaccination, 20. Reach the end of the study, 21. The researcher shall decide whether to continue to participate in the study if the new discovery or occurrence after the previous dose of vaccine does not meet the inclusion criteria of the first dose or meets the exclusion criteria of the first dose, 22. Other exclusion reasons considered by researchers, 23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial: -Non specific immunoglobulins were used during the study, -Continuous oral or drip steroid hormone for 14 days. 24. Items 18-23 above are the exclusion criteria for the second dose.

1. Novel coronavirus infection confirmed cases, 2. History of SARS and mers infection (self report, on-site inquiry), 3. Fever (axillary temperature > 37.0 degrees C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before inoculation, 4. The axillary temperature was more than 37.0 degrees C before inoculation, 5. Novel coronavirus inactivated vaccine has been sensitization to severe allergic reactions (such as acute allergic reaction, urticaria, eczema, dyspnea, neurovascular edema or abdominal pain). 6. History of convulsion, epilepsy, encephalopathy or mental illness or family history, 7. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc, 8. Severe liver and kidney diseases, drug uncontrollable hypertension (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg), diabetic complications, malignant tumor, acute attack of various acute or chronic diseases, 9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10. Known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors, 11. History of coagulation dysfunction (such as coagulation factor deficiency, coagulation diseases), 12. Receiving anti TB treatment, 13. Those who received immunoenhancement or immunosuppressive therapy within 3 months (continued oral or drip for more than 14 days), 14. Vaccinated with live attenuated vaccine within one month before vaccination and other vaccines within 14 days before vaccination, 15. Received blood products within 3 months before vaccination, 16. Received other research drugs within 6 months before vaccination, 17. The researcher judged other situations not suitable to participate in this clinical trial, 18. Severe allergic reaction and high fever (axillary temperature >= 39.0 degrees C) lasting for three days after the previous dose of vaccination, 19. Serious adverse reactions related to the previous dose of vaccination, 20. Reach the end of the study, 21. The researcher shall decide whether to continue to participate in the study if the new discovery or occurrence after the previous dose of vaccine does not meet the inclusion criteria of the first dose or meets the exclusion criteria of the first dose, 22. Other exclusion reasons considered by researchers, 23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial: -Non specific immunoglobulins were used during the study, -Continuous oral or drip steroid hormone for 14 days. 24. Items 18-23 above are the exclusion criteria for the second dose.

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

1. Confirmed acute cases of SARS-CoV-2 Infection, 2. Have a history of SARS, MERS infection (self-report, on-site inquiry), 3. Fever (axillary temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination, 4. Axillary body temperature > 37.0 degree C before vaccination, 5. Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred, 6. Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history, 7. With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., 8. With severe liver diseases, severe kidney diseases , uncontrollable hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases, 9. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10. With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors, 11. Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease), 12. Receiving anti-TB therapy, 13. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days), 14. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination, 15. Received blood products within 3 months before this vaccination, 16. Received other research drugs within 6 months before this vaccination, 17. Other circumstances judged by investigators that are not suitable for this clinical trial, 18. Patients with high fever (axillary temperature >=39.0 degree C) lasting for 3 days after the previous dose of vaccine and severe allergic reaction, 19. Serious adverse reactions with causal relationship with the previous dose of vaccine, 20. Reach the endpoint of a study, 21. for the subjects newly identified or newly co-curred which does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose after the previous dose of vaccine is vaccinated, the investigator shall determine whether they should continue to participate in the trial, 22. Other reasons for exclusion that investigator believes, 23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial: - Non-specific immunoglobulins were used during the study, - Continuous oral or IV administration of steroid hormones for 14 days, 24. above 18-23 criteria is the exclusion criteria of the second dose.

1. Confirmed acute cases of SARS-CoV-2 Infection, 2. Have a history of SARS, MERS infection (self-report, on-site inquiry), 3. Fever (axillary temperature > 37.0 degree C), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination, 4. Axillary body temperature > 37.0 degree C before vaccination, 5. Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred, 6. Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history, 7. With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., 8. With severe liver diseases, severe kidney diseases , uncontrollable hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases, 9. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases, 10. With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors, 11. Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease), 12. Receiving anti-TB therapy, 13. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days), 14. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination, 15. Received blood products within 3 months before this vaccination, 16. Received other research drugs within 6 months before this vaccination, 17. Other circumstances judged by investigators that are not suitable for this clinical trial, 18. Patients with high fever (axillary temperature >=39.0 degree C) lasting for 3 days after the previous dose of vaccine and severe allergic reaction, 19. Serious adverse reactions with causal relationship with the previous dose of vaccine, 20. Reach the endpoint of a study, 21. for the subjects newly identified or newly co-curred which does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose after the previous dose of vaccine is vaccinated, the investigator shall determine whether they should continue to participate in the trial, 22. Other reasons for exclusion that investigator believes, 23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial: - Non-specific immunoglobulins were used during the study, - Continuous oral or IV administration of steroid hormones for 14 days, 24. above 18-23 criteria is the exclusion criteria of the second dose.