Created at Source Raw Value Validated value
March 14, 2021, 1 a.m. irct

Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days History of SARS-CoV-2 infection (Only in immunogenicity subsample Fever or at least two of these symptoms: Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination History of severe allergic reaction to vaccination or allergic reactions to Inactivated vaccine components Known case of tuberculosis, hepatitis B or hepatitis C History of coagulopathy History of splenectomy Uncontrolled hypertension, uncontrolled diabetes, uncontrolled chronic cardiac, renal, neurologic, or severe pulmonary disease Acute diseases or an exacerbation of a chronic disease in the last 7 days Any malignancy, immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months or planning to use in the next year Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse in the last 12 months caused medical, familial or occupational problems Receiving immunoglobulins or blood products in 3 months before inoculation or planning to use in the next year Receiving any other investigational drug in 6 months before inoculation Having a plan to participate in a drug trial during the study period Planning to receive any vaccination in on month after inoculation History of severe mental disorders affecting the participation in the study Pregnant or lactating women or those who intend to become pregnant during the study period History of travel abroad in the last 14 days Any other condition that makes a person inappropriate for participation based on the investigator opinion

Confirmed, suspected, or asymptomatic COVID-19 detected by PCR at baseline History of contact with a person with SARS-CoV-2 infection (positive PCR test) during the last 14 days History of SARS-CoV-2 infection (Only in immunogenicity subsample Fever or at least two of these symptoms: Dry cough, severe fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, dyspnea, and shortness of breath during the 14 days prior to vaccination History of severe allergic reaction to vaccination or allergic reactions to Inactivated vaccine components Known case of tuberculosis, hepatitis B or hepatitis C History of coagulopathy History of splenectomy Uncontrolled hypertension, uncontrolled diabetes, uncontrolled chronic cardiac, renal, neurologic, or severe pulmonary disease Acute diseases or an exacerbation of a chronic disease in the last 7 days Any malignancy, immunodeficiency, HIV, lymphoma, leukemia, or other autoimmune diseases Receiving immunomodulators or immunosuppressors at least 14 days in the past 3 months or planning to use in the next year Receiving live vaccine in one month or other vaccines in 14 days before inoculation History of drug or alcohol abuse in the last 12 months caused medical, familial or occupational problems Receiving immunoglobulins or blood products in 3 months before inoculation or planning to use in the next year Receiving any other investigational drug in 6 months before inoculation Having a plan to participate in a drug trial during the study period Planning to receive any vaccination in on month after inoculation History of severe mental disorders affecting the participation in the study Pregnant or lactating women or those who intend to become pregnant during the study period History of travel abroad in the last 14 days Any other condition that makes a person inappropriate for participation based on the investigator opinion