Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. 2. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). 4. subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. 5. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. 6. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. 7. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. 8. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: * diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. * chronic pulmonary disease, asthma or wheezing. * chronic liver disease or suspected active hepatitis. * clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. * personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. * any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. * personal or family history of guillain-barré syndrome. * bleeding diathesis or condition associated with prolonged bleeding. * history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. * dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. 9. subject who has any of the following prior medication histories: * received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. * received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. * received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. * received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. * used bronchodilator within 90 days prior to the screening visit. 10. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. 11. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. 12. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. 13. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. 14. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. 15. subject who is not suitable to participate in this study as judged by the investigator.

1. subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. 2. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). 4. subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. 5. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. 6. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. 7. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. 8. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: * diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. * chronic pulmonary disease, asthma or wheezing. * chronic liver disease or suspected active hepatitis. * clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. * personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. * any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. * personal or family history of guillain-barré syndrome. * bleeding diathesis or condition associated with prolonged bleeding. * history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. * dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. 9. subject who has any of the following prior medication histories: * received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. * received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. * received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. * received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. * used bronchodilator within 90 days prior to the screening visit. 10. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. 11. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. 12. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. 13. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. 14. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. 15. subject who is not suitable to participate in this study as judged by the investigator.

Nov. 16, 2021, 6:30 p.m. usa

subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. chronic pulmonary disease, asthma or wheezing. chronic liver disease or suspected active hepatitis. clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. personal or family history of guillain-barré syndrome. bleeding diathesis or condition associated with prolonged bleeding. history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. subject who has any of the following prior medication histories: received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. used bronchodilator within 90 days prior to the screening visit. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. subject who is not suitable to participate in this study as judged by the investigator.

subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. chronic pulmonary disease, asthma or wheezing. chronic liver disease or suspected active hepatitis. clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. personal or family history of guillain-barré syndrome. bleeding diathesis or condition associated with prolonged bleeding. history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. subject who has any of the following prior medication histories: received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. used bronchodilator within 90 days prior to the screening visit. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. subject who is not suitable to participate in this study as judged by the investigator.

Nov. 4, 2021, 1:30 p.m. usa

1. subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. 2. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). 4. subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. 5. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. 6. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. 7. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. 8. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: - diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. - chronic pulmonary disease, asthma or wheezing. - chronic liver disease or suspected active hepatitis. - clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. - personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. - any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. - personal or family history of guillain-barré syndrome. - bleeding diathesis or condition associated with prolonged bleeding. - history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. - dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. 9. subject who has any of the following prior medication histories: - received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. - received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. - received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. - received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. - used bronchodilator within 90 days prior to the screening visit. 10. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. 11. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. 12. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. 13. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. 14. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. 15. subject who is not suitable to participate in this study as judged by the investigator.

1. subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or subjects who are sponsor employees directly involved in the conduct of the trial. 2. any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. subject with positive serology test results for human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) at the screening visit (v0). 4. subject with positive test result for covid-19 antigen rapid test at the screen visit or v1 prior to the 1st dosing. 5. subject with influenza-like illness as defined by any of the following symptoms at the screening visit or before randomization: fever (tympanic temperature ≥ 38°c), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat. 6. participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the screening visit and/or during study participation. 7. subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent covid-19 or plan simultaneous participation in another interventional study to prevent or treat covid-19. 8. subject with any following ongoing disease or medical history in medical chart or by verbal confirmation: - diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the screening visit. - chronic pulmonary disease, asthma or wheezing. - chronic liver disease or suspected active hepatitis. - clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure. - personal or family history of immune disorders, including systemic lupus erythematosus (sle), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and type 1 diabetes. - any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency. - personal or family history of guillain-barré syndrome. - bleeding diathesis or condition associated with prolonged bleeding. - history of anaphylaxis, urticarial or severe adverse reaction associated with a vaccine or adimrsc-2f or aluminum. - dermatologic conditions that could affect local solicited adverse event assessment per the investigator's opinion. 9. subject who has any of the following prior medication histories: - received any vaccine (live, inactivated, or bacterial) within 30 days prior to the screening visit. - received any blood/plasma products or immunoglobulin within 90 days prior to the screening visit. - received any systemic corticosteroids or steroids within 30 days prior to the first dosing. topical, inhaled/nebulized, intra-articular, or nasal corticosteroid/ steroids are permitted. - received treatment with immunosuppressive therapy, including cytotoxic agents, immunosupressants or system corticosteroids for organ transplant, cancer, or an autoimmune disease, or planned receipt for disease treatment during study period. - used bronchodilator within 90 days prior to the screening visit. 10. subject with current use or history of chronic smoking (defined as ≥ 1 cigarette per day) in the medical chart or by verbal confirmation within 1 year prior to the screening visit. 11. subject with the history of illegal substance use or alcohol abuse in the medical chart or by verbal confirmation within 2 years prior to the screening visit. 12. female subject who is pregnant or lactating at the screening visit or visit 1 or plan to be pregnant during the study period. 13. subject who has donated ≥ 250 ml of blood product within 28 days prior to the screening visit or who plans to donate blood products during the study period. 14. subject with levels of creatine phosphokinase outside of the reference range at the screening visit. 15. subject who is not suitable to participate in this study as judged by the investigator.