Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential currently breastfeeding current or past participation in a coronavirus (mers-cov, sars-cov-2) vaccine study administration of an investigational agent within 6 months of the 1st dose administration of a vaccine within 4 weeks prior to the 1st dose administration of immune globulin within 16 weeks of enrollment administration of an anti-tnfα inhibitor such as infliximab, adalimumab, etanercept, or anti-cd20 monoclonal antibody rituximab within 24 weeks prior to enrollment current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids administration of any immunosuppressive drug or immunomodulator within 3 months of the first dose history of bone marrow transplantation current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment respiratory disease (ex. asthma, chronic obstructive lung disease) cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia) hypertension (systolic pressure >150mmhg or diastolic pressure >95mmhg) confirmed diabetes severe allergic reaction or anaphylactic reaction after vaccination in the past immunosuppresion including immunodeficiency disease or family history positive of serum test at screening (hepatitis b, hepatitis a, hiv, hepatitis c) baseline screening lab(s) with non clinical significant abnormality serious adverse reaction to a drug containing investigational product (gls-5310) 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 history of pcr-confirmed infection with sars-cov-2 at screening 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 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration healthcare workers participating in the medical examination of patients infected with covid-19 not willing to allow storage and future use of samples for sars-cov-2 related research prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential currently breastfeeding current or past participation in a coronavirus (mers-cov, sars-cov-2) vaccine study administration of an investigational agent within 6 months of the 1st dose administration of a vaccine within 4 weeks prior to the 1st dose administration of immune globulin within 16 weeks of enrollment administration of an anti-tnfα inhibitor such as infliximab, adalimumab, etanercept, or anti-cd20 monoclonal antibody rituximab within 24 weeks prior to enrollment current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids administration of any immunosuppressive drug or immunomodulator within 3 months of the first dose history of bone marrow transplantation current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment respiratory disease (ex. asthma, chronic obstructive lung disease) cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia) hypertension (systolic pressure >150mmhg or diastolic pressure >95mmhg) confirmed diabetes severe allergic reaction or anaphylactic reaction after vaccination in the past immunosuppresion including immunodeficiency disease or family history positive of serum test at screening (hepatitis b, hepatitis a, hiv, hepatitis c) baseline screening lab(s) with non clinical significant abnormality serious adverse reaction to a drug containing investigational product (gls-5310) 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 history of pcr-confirmed infection with sars-cov-2 at screening 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 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration healthcare workers participating in the medical examination of patients infected with covid-19 not willing to allow storage and future use of samples for sars-cov-2 related research prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

Dec. 19, 2020, 12:31 a.m. usa

1. current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential 2. currently breastfeeding 3. current or past participation in a coronavirus (mers-cov, sars-cov-2) vaccine study 4. administration of an investigational agent within 6 months of the 1st dose 5. administration of a vaccine within 4 weeks prior to the 1st dose 6. administration of immune globulin within 16 weeks of enrollment 7. administration of an anti-tnfα inhibitor such as infliximab, adalimumab, etanercept, or anti-cd20 monoclonal antibody rituximab within 24 weeks prior to enrollment 8. current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids 9. administration of any immunosuppressive drug or immunomodulator within 3 months of the first dose 10. history of bone marrow transplantation 11. current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment 12. respiratory disease (ex. asthma, chronic obstructive lung disease) 13. cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia) 14. hypertension (systolic pressure >150mmhg or diastolic pressure >95mmhg) 15. confirmed diabetes 16. severe allergic reaction or anaphylactic reaction after vaccination in the past 17. immunosuppresion including immunodeficiency disease or family history 18. positive of serum test at screening (hepatitis b, hepatitis a, hiv, hepatitis c) 19. baseline screening lab(s) with non clinical significant abnormality 20. serious adverse reaction to a drug containing investigational product (gls-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 21. history of hypersensitivity to vaccination such as guillain-barre syndrome 22. history of pcr-confirmed infection with sars-cov-2 at screening 23. 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 24. 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 25. healthcare workers participating in the medical examination of patients infected with covid-19 26. not willing to allow storage and future use of samples for sars-cov-2 related research 27. prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness 28. any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint

1. current or planned pregnancy through to 4 weeks post-boost vaccination for women of childbearing potential 2. currently breastfeeding 3. current or past participation in a coronavirus (mers-cov, sars-cov-2) vaccine study 4. administration of an investigational agent within 6 months of the 1st dose 5. administration of a vaccine within 4 weeks prior to the 1st dose 6. administration of immune globulin within 16 weeks of enrollment 7. administration of an anti-tnfα inhibitor such as infliximab, adalimumab, etanercept, or anti-cd20 monoclonal antibody rituximab within 24 weeks prior to enrollment 8. current daily treatment of systemic corticosteroids of 20 mg of prednisone or greater, dexamethasone of 3 mg or greater; or the equivalent dose of other systemic corticosteroids 9. administration of any immunosuppressive drug or immunomodulator within 3 months of the first dose 10. history of bone marrow transplantation 11. current or planned chemotherapy treatment for hematologic or solid tumor during study period or treatment during the 5 years prior to enrollment 12. respiratory disease (ex. asthma, chronic obstructive lung disease) 13. cardiovascular disease (ex. myocardial ischemia, congestive heart failure, cardiomyopathy, clinically significant arrhythmia) 14. hypertension (systolic pressure >150mmhg or diastolic pressure >95mmhg) 15. confirmed diabetes 16. severe allergic reaction or anaphylactic reaction after vaccination in the past 17. immunosuppresion including immunodeficiency disease or family history 18. positive of serum test at screening (hepatitis b, hepatitis a, hiv, hepatitis c) 19. baseline screening lab(s) with non clinical significant abnormality 20. serious adverse reaction to a drug containing investigational product (gls-5310) or other ingredients of the same categories or to a vaccine or antibiotic, nonsteroidal anti-inflammatory disease control, etc. or an allergic history 21. history of hypersensitivity to vaccination such as guillain-barre syndrome 22. history of pcr-confirmed infection with sars-cov-2 at screening 23. 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 24. 37.5 degrees, cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to administration 25. healthcare workers participating in the medical examination of patients infected with covid-19 26. not willing to allow storage and future use of samples for sars-cov-2 related research 27. prisoner or subjects who are compulsorily detained for treatment of a psychiatric illness 28. any illness or condition that, in the opinion of the investigator, may affect the safety of the subject or the evaluation of a study endpoint