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

1. participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). 2. previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction \[pcr\] or positive serology test prior to the first trial vaccine administration). 3. use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 4. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. 5. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. 6. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for \> 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. 7. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. 8. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. 9. history of potential immune-mediated disease. 10. history of angioedema. 11. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. 12. history of or current alcohol and/or drug abuse. 13. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). 14. administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. 15. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. 16. foreseeable non-compliance with protocol as judged by the investigator. 17. for females: pregnancy or lactation. 18. history of any anaphylactic reactions. 19. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. 20. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. 21. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

1. participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). 2. previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction \[pcr\] or positive serology test prior to the first trial vaccine administration). 3. use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 4. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. 5. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. 6. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for \> 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. 7. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. 8. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. 9. history of potential immune-mediated disease. 10. history of angioedema. 11. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. 12. history of or current alcohol and/or drug abuse. 13. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). 14. administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. 15. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. 16. foreseeable non-compliance with protocol as judged by the investigator. 17. for females: pregnancy or lactation. 18. history of any anaphylactic reactions. 19. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. 20. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. 21. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

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

participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction [pcr] or positive serology test prior to the first trial vaccine administration). use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. history of potential immune-mediated disease. history of angioedema. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. history of or current alcohol and/or drug abuse. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. foreseeable non-compliance with protocol as judged by the investigator. for females: pregnancy or lactation. history of any anaphylactic reactions. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction [pcr] or positive serology test prior to the first trial vaccine administration). use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. history of potential immune-mediated disease. history of angioedema. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. history of or current alcohol and/or drug abuse. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. foreseeable non-compliance with protocol as judged by the investigator. for females: pregnancy or lactation. history of any anaphylactic reactions. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

April 11, 2021, 12:31 a.m. usa

1. participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). 2. previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction [pcr] or positive serology test prior to the first trial vaccine administration). 3. use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 4. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. 5. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. 6. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. 7. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. 8. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. 9. history of potential immune-mediated disease. 10. history of angioedema. 11. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. 12. history of or current alcohol and/or drug abuse. 13. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). 14. administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. 15. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. 16. foreseeable non-compliance with protocol as judged by the investigator. 17. for females: pregnancy or lactation. 18. history of any anaphylactic reactions. 19. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. 20. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. 21. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).

1. participant ill or febrile (body temperature ≥38.0°c) within 72 hours prior to screening and/or symptoms suggestive of coronavirus disease 2019 (covid-19) within the past 14 days prior to screening (ill or febrile participants may be re-scheduled within the predefined interval when no longer presenting symptoms). 2. previous or currently active sars-cov-2 infection (currently as confirmed by reactive polymerase chain reaction [pcr] or positive serology test prior to the first trial vaccine administration). 3. use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period. 4. receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration. 5. receipt of any investigational or licensed/authorized sars-cov-2 or other coronavirus vaccine, including non-specific vaccines such as bacillus calmette-guérin, prior to the administration of the trial vaccine or planned administration during the trial. 6. any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for > 14 days total within 6 months preceding the administration of trial vaccine or planned use during the trial. for corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 days or more. the use of inhaled, topical, or localized injections of corticosteroids (e.g., for joint pain/inflammation) is permitted. 7. receipt of any lipid nanoparticles (lnp)-formulated messenger ribonucleic acid vaccine prior to the administration of the trial vaccine. 8. any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis b virus infection and hepatitis c virus infection. 9. history of potential immune-mediated disease. 10. history of angioedema. 11. any known allergy to any component of investigational cvncov or aminoglycoside antibiotics. 12. history of or current alcohol and/or drug abuse. 13. history of severe acute respiratory syndrome (sars) or middle east respiratory syndrome (self-reported). 14. administration of immunoglobulins (igs) and/or any blood products within the 3 months preceding the administration of any dose of the trial vaccine or planned administration during the trial. 15. participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes trial participation (e.g., may increase the risk of trial participation, render the participant unable to meet the requirements of the trial, or may interfere with the participant's trial evaluations). these include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological and psychiatric illnesses. however, those with controlled and stable cases can be included in the trial. 16. foreseeable non-compliance with protocol as judged by the investigator. 17. for females: pregnancy or lactation. 18. history of any anaphylactic reactions. 19. participants with a significant bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder) or prior history of significant bleeding or bruising following intramuscular (im) injections or venipuncture. 20. participants employed by the sponsor, investigator or trial site, or relatives of research staff working on this trial. 21. participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).