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April 21, 2022, 7:30 p.m. oms

Exclusion criteria for first dose vaccination: 1. Women who are in the menstrual period (1st to 4th day of menstrual cramps) or breastfeeding on the day of vaccination, or men whose partners plan to become pregnant within 12 months from the screening period to the full immunization, or who plan to donate sperm and eggs By, 2. Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have contact history with new coronavirus confirmed or suspected cases within 1 month before signing the informed consent form, or have high risk areas or overseas travel experience, or new coronavirus Infected persons or carriers: serum anti-SARS-CoV-2 IgG, IgM-specific antibodies are positive, or throat swab specimens are positive for SARS-CoV-2 nucleic acid, 3. Persons with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody, 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Acute disease or acute exacerbation of chronic disease within 2 weeks before the first dose of vaccine, or fever (armpit temperature = 37.3?) or symptoms of upper respiratory tract infection within 7 days before the first dose of vaccine, 6. Previous history of alcohol or any serious adverse reactions to vaccines or drugs (for example: allergy, urticaria, skin eczema, allergic purpura, dyspnea, angioedema, etc.), or a history of acetaminophen allergy, 7. Have received any vaccine within 1 month before the first dose of vaccine, 8. Those who cannot tolerate venipuncture, those who have a history of fainting with needles and blood, 9. Has a hereditary bleeding tendency or coagulation dysfunction, or has a history of thrombosis or bleeding, and the test results of coagulation-related indicators are abnormal, 10. Has been diagnosed with congenital or acquired immunodeficiency (eg: HIV infection), 11. Asplenia, functional asplenia, and surgical removal of other vital organs for any reason, 12. Patients with abnormal clinical manifestations and serious diseases that need to be excluded in the past, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system and history of malignant tumors, excluding history of stable chronic diseases, such as diabetes, hypertension, etc., 13. Those who have undergone surgery within 3 months before signing the informed consent form, or those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial or within 3 months after the end of the trial, 14. Those who donated blood or lost blood (=450 mL) within 3 months before signing the informed consent, received blood transfusion or used blood products, or planned to donate blood during the trial, 15. Have used any investigational or unregistered product (drug, vaccine, biological product or device) within 3 months before signing the informed consent, or plan to use it during the study, 16. Received immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term application of systemic glucocorticoid therapy (systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs ), but topical application (such as ointment, eye drops, inhaler or

Exclusion criteria for first dose vaccination: 1. Women who are in the menstrual period (1st to 4th day of menstrual cramps) or breastfeeding on the day of vaccination, or men whose partners plan to become pregnant within 12 months from the screening period to the full immunization, or who plan to donate sperm and eggs By, 2. Those who have been diagnosed with new coronavirus pneumonia cases or suspected cases, have contact history with new coronavirus confirmed or suspected cases within 1 month before signing the informed consent form, or have high risk areas or overseas travel experience, or new coronavirus Infected persons or carriers: serum anti-SARS-CoV-2 IgG, IgM-specific antibodies are positive, or throat swab specimens are positive for SARS-CoV-2 nucleic acid, 3. Persons with positive tests for hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum specific antibody, and human immunodeficiency virus antibody, 4. There is a history of SARS, MERS and other coronavirus infection or disease history, 5. Acute disease or acute exacerbation of chronic disease within 2 weeks before the first dose of vaccine, or fever (armpit temperature = 37.3?) or symptoms of upper respiratory tract infection within 7 days before the first dose of vaccine, 6. Previous history of alcohol or any serious adverse reactions to vaccines or drugs (for example: allergy, urticaria, skin eczema, allergic purpura, dyspnea, angioedema, etc.), or a history of acetaminophen allergy, 7. Have received any vaccine within 1 month before the first dose of vaccine, 8. Those who cannot tolerate venipuncture, those who have a history of fainting with needles and blood, 9. Has a hereditary bleeding tendency or coagulation dysfunction, or has a history of thrombosis or bleeding, and the test results of coagulation-related indicators are abnormal, 10. Has been diagnosed with congenital or acquired immunodeficiency (eg: HIV infection), 11. Asplenia, functional asplenia, and surgical removal of other vital organs for any reason, 12. Patients with abnormal clinical manifestations and serious diseases that need to be excluded in the past, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system and history of malignant tumors, excluding history of stable chronic diseases, such as diabetes, hypertension, etc., 13. Those who have undergone surgery within 3 months before signing the informed consent form, or those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial or within 3 months after the end of the trial, 14. Those who donated blood or lost blood (=450 mL) within 3 months before signing the informed consent, received blood transfusion or used blood products, or planned to donate blood during the trial, 15. Have used any investigational or unregistered product (drug, vaccine, biological product or device) within 3 months before signing the informed consent, or plan to use it during the study, 16. Received immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term application of systemic glucocorticoid therapy (systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs ), but topical application (such as ointment, eye drops, inhaler or

Sept. 1, 2021, 11 p.m. oms

Exclusion Criteria for Dose 1: Subjects who meet any of the following exclusion criteria should be excluded from the study: 1. Individuals whose results from a complete physical examination do not meet the health standards, mainly include: 1) Abnormal vital signs with clinical significance (pulse < 50/min or > 100/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg for a conscious adult), 2) BMI < 18 kg/m^2 or > 30 kg/m^2, 3) In the screening window period, the laboratory test value exceeds 1.2 ULN, and is determined by the investigator to be clinically significant, 2. Women in menstrual period at the day of administration, women in lactation period, or women who plan to conceive within 12 months from screening period to the end of complete series, men whose spouse plans to conceive, or those who plan to donate sperm and eggs, 3. Individuals with a history of vaccination with any COVID-19 vaccines, 4. Individuals with prior diagnosis as COVID-19 cases or suspected cases. Individuals who have a history of contact with COVID-19 cases or suspected cases within 1 month before signing the informed consent, or those who have overseas travel history or have traveled to areas with high incidence of COVID-19, COVID-19 infectors or carriers: those with positive results for serum SARS-CoV-2-specific antibodies or SARS-CoV-2 nucleic acid in throat swabs, 5. Individuals who are tested positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum-specific antibody and human immunodeficiency virus antibody, 6. Individuals with a history of infections or diseases caused by SARS, MERS or other coronavirus, 7. Individuals who have acute diseases or are in acute attack of chronic diseases within 2 weeks prior to Dose 1, or have fever (axillary temperature = 37.3?) or upper respiratory tract infection within 7 days prior to Dose 1, 8. Individuals with a history of severe side effects induced by alcohol, any vaccine or any drug, (such as allergy, urticaria, eczema, dyspnea, angioneurotic edema, etc.), individuals with a history of allergy to acetaminophen, 9. Individuals who have been vaccinated with any vaccine within 1 month prior to Dose 1, 10. Individuals who cannot tolerate the venipuncture and who have fainting history during acupuncture or at the sight of blood, 11. Individuals who have hereditary bleeding tendency or coagulation dysfunction, or have history of thrombosis or bleeding, and those with abnormal detection results of coagulation-related measurements, 12. Individuals who have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 13. Individuals who have asplenia or functional asplenia, or have other important organs removed by surgery for any reason, 14. Individuals who previously have serious diseases with abnormal clinical manifestations that needed to be excluded, including, but not limited to history of systemic diseases and malignant tumors for nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system, excluding stable chronic diseases, such as diabetes, hypertension, etc., 15. Individuals who have undergone any surgeries within 3 months prior to the signing of informed consent, or plan to have any surgeries during the trial period, 16. Individuals who had blood donation or blood loss (>=450 mL), blood transfusion or us

Exclusion Criteria for Dose 1: Subjects who meet any of the following exclusion criteria should be excluded from the study: 1. Individuals whose results from a complete physical examination do not meet the health standards, mainly include: 1) Abnormal vital signs with clinical significance (pulse < 50/min or > 100/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg for a conscious adult), 2) BMI < 18 kg/m^2 or > 30 kg/m^2, 3) In the screening window period, the laboratory test value exceeds 1.2 ULN, and is determined by the investigator to be clinically significant, 2. Women in menstrual period at the day of administration, women in lactation period, or women who plan to conceive within 12 months from screening period to the end of complete series, men whose spouse plans to conceive, or those who plan to donate sperm and eggs, 3. Individuals with a history of vaccination with any COVID-19 vaccines, 4. Individuals with prior diagnosis as COVID-19 cases or suspected cases. Individuals who have a history of contact with COVID-19 cases or suspected cases within 1 month before signing the informed consent, or those who have overseas travel history or have traveled to areas with high incidence of COVID-19, COVID-19 infectors or carriers: those with positive results for serum SARS-CoV-2-specific antibodies or SARS-CoV-2 nucleic acid in throat swabs, 5. Individuals who are tested positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum-specific antibody and human immunodeficiency virus antibody, 6. Individuals with a history of infections or diseases caused by SARS, MERS or other coronavirus, 7. Individuals who have acute diseases or are in acute attack of chronic diseases within 2 weeks prior to Dose 1, or have fever (axillary temperature = 37.3?) or upper respiratory tract infection within 7 days prior to Dose 1, 8. Individuals with a history of severe side effects induced by alcohol, any vaccine or any drug, (such as allergy, urticaria, eczema, dyspnea, angioneurotic edema, etc.), individuals with a history of allergy to acetaminophen, 9. Individuals who have been vaccinated with any vaccine within 1 month prior to Dose 1, 10. Individuals who cannot tolerate the venipuncture and who have fainting history during acupuncture or at the sight of blood, 11. Individuals who have hereditary bleeding tendency or coagulation dysfunction, or have history of thrombosis or bleeding, and those with abnormal detection results of coagulation-related measurements, 12. Individuals who have been diagnosed with congenital or acquired immunodeficiency (e.g., HIV infection), 13. Individuals who have asplenia or functional asplenia, or have other important organs removed by surgery for any reason, 14. Individuals who previously have serious diseases with abnormal clinical manifestations that needed to be excluded, including, but not limited to history of systemic diseases and malignant tumors for nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone system, excluding stable chronic diseases, such as diabetes, hypertension, etc., 15. Individuals who have undergone any surgeries within 3 months prior to the signing of informed consent, or plan to have any surgeries during the trial period, 16. Individuals who had blood donation or blood loss (>=450 mL), blood transfusion or us