Created at Source Raw Value Validated value
July 30, 2021, 1:30 p.m. oms

First dose exclusion criteria - SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection - SARS-CoV-2 Nucleic acid test positive - Have a history of SARS, MERS infection (self-report, on-site inquiry) - Fever (axillary temperature > 37.0 &#8451,), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. - Axillary body temperature > 37.0 &#8451, before vaccination - 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. - Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history. - Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure &#8805, 140 mmHg, diastolic blood pressure &#8805, 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases. - Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases. - Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease) - Receiving anti-TB therapy. - Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days) - Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination. - Received blood products within 3 months before this vaccination - Received other research drugs within 6 months before this vaccination. - Investigator judged other circumstances that are not suitable for this clinical trial. Second dose exclusion criteria - Patients with high fever (axillary temperature &#8805, 39.0 &#8451,) lasting for 3 days after the previous dose of vaccine and severe allergic reaction, - Serious adverse reactions with causal relationship with the previous dose of vaccine, - Reach the endpoint of a study, - 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, - Other reasons for exclusion that investigator believes. 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.

First dose exclusion criteria - SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection - SARS-CoV-2 Nucleic acid test positive - Have a history of SARS, MERS infection (self-report, on-site inquiry) - Fever (axillary temperature > 37.0 &#8451,), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. - Axillary body temperature > 37.0 &#8451, before vaccination - 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. - Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history. - Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure &#8805, 140 mmHg, diastolic blood pressure &#8805, 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases. - Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases. - Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease) - Receiving anti-TB therapy. - Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days) - Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination. - Received blood products within 3 months before this vaccination - Received other research drugs within 6 months before this vaccination. - Investigator judged other circumstances that are not suitable for this clinical trial. Second dose exclusion criteria - Patients with high fever (axillary temperature &#8805, 39.0 &#8451,) lasting for 3 days after the previous dose of vaccine and severe allergic reaction, - Serious adverse reactions with causal relationship with the previous dose of vaccine, - Reach the endpoint of a study, - 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, - Other reasons for exclusion that investigator believes. 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.