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

participants meeting any of the following criteria at the screening visit: 1. immunosuppresion including immunodeficiency disease or family history 2. any history of malignant disease within the past 5 years 3. scheduled to undergo any surgery or dental treatment during the study 4. having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. 5. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration 6. positive of serum test at screening 7. suspected of drug abuse or a history within 12 months prior to administration 8. active alcohol use or history of alcohol abuse 9. serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 10. history of hypersensitivity to vaccination such as guillain-barre syndrome 11. those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) 12. having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants 13. subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past 14. acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 15. other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study 16. history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration 17. having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration 18. pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening 19. fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study 20. any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

participants meeting any of the following criteria at the screening visit: 1. immunosuppresion including immunodeficiency disease or family history 2. any history of malignant disease within the past 5 years 3. scheduled to undergo any surgery or dental treatment during the study 4. having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. 5. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration 6. positive of serum test at screening 7. suspected of drug abuse or a history within 12 months prior to administration 8. active alcohol use or history of alcohol abuse 9. serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 10. history of hypersensitivity to vaccination such as guillain-barre syndrome 11. those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) 12. having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants 13. subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past 14. acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 15. other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study 16. history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration 17. having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration 18. pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening 19. fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study 20. any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

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

participants meeting any of the following criteria at the screening visit: immunosuppresion including immunodeficiency disease or family history any history of malignant disease within the past 5 years scheduled to undergo any surgery or dental treatment during the study having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration positive of serum test at screening suspected of drug abuse or a history within 12 months prior to administration active alcohol use or history of alcohol abuse serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history history of hypersensitivity to vaccination such as guillain-barre syndrome those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

participants meeting any of the following criteria at the screening visit: immunosuppresion including immunodeficiency disease or family history any history of malignant disease within the past 5 years scheduled to undergo any surgery or dental treatment during the study having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration positive of serum test at screening suspected of drug abuse or a history within 12 months prior to administration active alcohol use or history of alcohol abuse serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history history of hypersensitivity to vaccination such as guillain-barre syndrome those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

Oct. 26, 2020, 11:31 p.m. usa

participants meeting any of the following criteria at the screening visit: 1. immunosuppresion including immunodeficiency disease or family history 2. any history of malignant disease within the past 5 years 3. scheduled to undergo any surgery or dental treatment during the study 4. having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. 5. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration 6. positive of serum test at screening 7. suspected of drug abuse or a history within 12 months prior to administration 8. active alcohol use or history of alcohol abuse 9. serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 10. history of hypersensitivity to vaccination such as guillain-barre syndrome 11. those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) 12. having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants 13. subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past 14. acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 15. other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study 16. history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration 17. having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration 18. pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening 19. fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study 20. any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator

participants meeting any of the following criteria at the screening visit: 1. immunosuppresion including immunodeficiency disease or family history 2. any history of malignant disease within the past 5 years 3. scheduled to undergo any surgery or dental treatment during the study 4. having received immunoglobulin or blood-derived drugs or being expected to be administered within 3 months prior to administration. 5. having relied on antipsychotic drugs and narcotic analgesics within 6 months before administration 6. positive of serum test at screening 7. suspected of drug abuse or a history within 12 months prior to administration 8. active alcohol use or history of alcohol abuse 9. serious adverse reaction to a drug containing gx-19 or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 10. history of hypersensitivity to vaccination such as guillain-barre syndrome 11. those who have or with a history of disease corresponding to other hepatobiliary, kidneys, nervous systems (middle or peripheral), respiratory machines (e.g. asthma, pneumonia, etc., endocrine systems (uncontrolled diabetes, hyperlipidemia, etc.) and cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension), blood tumors, urinary machines, mental, musculoskeletal systems, immune system (rheumatoid arthritis, systemic arthritis, mumps, immunodeficiency disease) 12. having hemophilia at risk of causing serious bleeding when injected intramuscularly or receiving anticoagulants 13. subjects who have been contact with covid-19 infections in the past prior to administration, have been classified as covid-19 confirmed patients, medical patients or patients with symptoms or have been identified with sars and mers infection history in the past 14. acute fever, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 15. other vaccination history within 28 days prior to the administration or being scheduled to be inoculated during the study 16. history of having taken immunosuppressant or immune modifying drug within 3 months prior to administration 17. having participated and had clinical trial drug administration in another clinical trial or biological equivalence study within 6 months prior to the administration 18. pregnant or breastfeeding female, however, those are allowed to participate in the study only if they stop breastfeeding before participation (fertile female† must be negative in serum pregnancy test at screening 19. fertile female who do not agree to use effective contraception methods (condoms, contraceptive diaphragm, intrauterine contraceptive devices) during the study 20. any other clinically significant medical or psychiatric finding which is considered inappropriate by investigator