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

* subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: 1. history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. 2. individuals with behavioral or cognitive impairment in the opinion of the investigator. 3. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. 4. individuals with known or suspected impairment of the immune system, such as: 1. use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. 2. receipt of cancer chemotherapy within 5 years prior to day 1. 3. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. 4. known hiv or acquired immune deficiency syndrome. 5. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases \[pimds\]). 6. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. 7. being treated for tuberculosis. 5. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. 6. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. 7. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). 8. history of urticaria within 1 year prior to screening. 9. history of hereditary angioneurotic edema or acquired angioneurotic edema. 10. history of asplenia or functional asplenia. 11. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. 13. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (\>3 infections/year). 14. individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. 15. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. 16. individuals who faint at the sight of blood or needles. 17. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. 18. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. 19. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. 20. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). 21. individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. 22. any persons who are: 1. an employee of the study site, investigator, contract research organization (cro) or sponsor. 2. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.

* subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: 1. history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. 2. individuals with behavioral or cognitive impairment in the opinion of the investigator. 3. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. 4. individuals with known or suspected impairment of the immune system, such as: 1. use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. 2. receipt of cancer chemotherapy within 5 years prior to day 1. 3. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. 4. known hiv or acquired immune deficiency syndrome. 5. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases \[pimds\]). 6. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. 7. being treated for tuberculosis. 5. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. 6. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. 7. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). 8. history of urticaria within 1 year prior to screening. 9. history of hereditary angioneurotic edema or acquired angioneurotic edema. 10. history of asplenia or functional asplenia. 11. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. 13. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (\>3 infections/year). 14. individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. 15. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. 16. individuals who faint at the sight of blood or needles. 17. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. 18. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. 19. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. 20. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). 21. individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. 22. any persons who are: 1. an employee of the study site, investigator, contract research organization (cro) or sponsor. 2. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.

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

subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. individuals with behavioral or cognitive impairment in the opinion of the investigator. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. individuals with known or suspected impairment of the immune system, such as: use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. receipt of cancer chemotherapy within 5 years prior to day 1. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. known hiv or acquired immune deficiency syndrome. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases [pimds]). receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. being treated for tuberculosis. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). history of urticaria within 1 year prior to screening. history of hereditary angioneurotic edema or acquired angioneurotic edema. history of asplenia or functional asplenia. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (>3 infections/year). individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. individuals who faint at the sight of blood or needles. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. any persons who are: an employee of the study site, investigator, contract research organization (cro) or sponsor. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.

subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. individuals with behavioral or cognitive impairment in the opinion of the investigator. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. individuals with known or suspected impairment of the immune system, such as: use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. receipt of cancer chemotherapy within 5 years prior to day 1. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. known hiv or acquired immune deficiency syndrome. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases [pimds]). receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. being treated for tuberculosis. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). history of urticaria within 1 year prior to screening. history of hereditary angioneurotic edema or acquired angioneurotic edema. history of asplenia or functional asplenia. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (>3 infections/year). individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. individuals who faint at the sight of blood or needles. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. any persons who are: an employee of the study site, investigator, contract research organization (cro) or sponsor. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.

March 28, 2021, 12:31 a.m. usa

- subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: 1. history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. 2. individuals with behavioral or cognitive impairment in the opinion of the investigator. 3. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. 4. individuals with known or suspected impairment of the immune system, such as: 1. use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. 2. receipt of cancer chemotherapy within 5 years prior to day 1. 3. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. 4. known hiv or acquired immune deficiency syndrome. 5. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases [pimds]). 6. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. 7. being treated for tuberculosis. 5. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. 6. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. 7. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). 8. history of urticaria within 1 year prior to screening. 9. history of hereditary angioneurotic edema or acquired angioneurotic edema. 10. history of asplenia or functional asplenia. 11. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. 13. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (>3 infections/year). 14. individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. 15. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. 16. individuals who faint at the sight of blood or needles. 17. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. 18. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. 19. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. 20. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). 21. individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. 22. any persons who are: 1. an employee of the study site, investigator, contract research organization (cro) or sponsor. 2. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.

- subjects are excluded from the study if any of the following criteria apply at any time starting from screening up to day 1 prior to ip administration: 1. history of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the investigator within 12 months prior to screening. 2. individuals with behavioral or cognitive impairment in the opinion of the investigator. 3. individuals with any progressive or severe neurologic disorder, seizure disorder, or history of guillain-barré syndrome. 4. individuals with known or suspected impairment of the immune system, such as: 1. use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to day 1. use of inhaled, intranasal, or topical corticosteroids is allowed. note: systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the ip. 2. receipt of cancer chemotherapy within 5 years prior to day 1. 3. receipt of immunostimulants or immunosuppressants within 60 days prior to day 1. 4. known hiv or acquired immune deficiency syndrome. 5. subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases [pimds]). 6. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to day 1 or planned during the full length of the study. 7. being treated for tuberculosis. 5. history of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the ip. 6. individuals who have had a previous confirmed or suspected illness caused by sars-cov-1, sars-cov-2, or mers-cov. 7. individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the ip (day 1). 8. history of urticaria within 1 year prior to screening. 9. history of hereditary angioneurotic edema or acquired angioneurotic edema. 10. history of asplenia or functional asplenia. 11. history of platelet disorder or other bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 12. current febrile illness or body temperature ≥38.0°c or other moderate to severe illness within 24 hours of ip administration on day 1. this condition is considered to be temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met. 13. any current active infections, including localized infections, or any recent history (within 1 week prior to ip administration) of active infections or cough; or a history of recurrent or chronic infections (>3 infections/year). 14. individuals with a history of drug or alcohol abuse (with an average intake exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 ml of beer, 150 ml of wine, or 45 ml of spirits) or drug addiction (including soft drugs like cannabis products) within the past 2 years. 15. current heavy smoker, defined as smoking ≥20 cigarettes/day (1 pack or equivalent), or a former heavy smoker who was an active smoker within the past 1 year prior to screening. 16. individuals who faint at the sight of blood or needles. 17. participation in another interventional clinical study (including a bioequivalence study) with an investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of the ip. 18. individuals who have received any prior investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1, sars-cov-2, and mers-cov. 19. individuals who have received any other licensed vaccines within 14 days (for inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to enrollment in this study, or those who are planning to receive any vaccine within 30 days before the first dose of ip or during the study, with the exception of the seasonal influenza vaccine. 20. individuals must not have donated blood for 30 days prior to day 1 and must agree to not donate blood for 6 months after day 1 (receipt of first dose of the ip). 21. individuals with any condition that, in the opinion of the investigator, would interfere with the study objectives or pose additional subject risk. 22. any persons who are: 1. an employee of the study site, investigator, contract research organization (cro) or sponsor. 2. a first-degree relative of an employee of the study site, the investigator, cro, or the sponsor.