Created at Source Raw Value Validated value
May 16, 2021, 12:32 a.m. usa

None

None

Dec. 16, 2020, 10:02 a.m. usa

1. history of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. chronic condition that are not included on the cdc's list of subjects at higher risk for severe illness from sars-cov-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (day 1), with no medication changes, and no hospitalization in the past 6 months). 2. history of any medical conditions that place subjects at higher risk for severe illness due to sars-cov-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, severe obesity. 3. history of ongoing clinical condition or medication or treatments that may adversely affect the immune system. 4. individuals who are seropositive or rt-pcr positive for sars-cov-2 at screening. 5. individuals who are rt-pcr positive for sars-cov-2 at screening or prior to second dose of tap-covid-19 vaccine. 6. individuals who are at increased risk of exposure to sars-cov-2 (eg, healthcare workers, emergency responders). 7. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. 8. living in a group care facility (eg, assisted living or nursing home). 9. individuals with any elevated (grade 1 or higher) laboratory test assessed as clinically significant for age by the investigator at screening. 10. individuals with any elevated (grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). 11. active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "active" is defined as having received treatment within the past 5 years. 12. long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed). 13. history of autoimmune or inflammatory disease. 14. women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization. 15. history of guillain-barré syndrome. 16. history of anaphylactic-type reaction to injected vaccines. 17. known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal. 18. history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening. 19. acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator). 20. individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study. 21. receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study. 22. individuals who intend to donate blood within 6 months after the first vaccination. 23. individuals using prescription medications for prophylaxis of sars-cov-2. 24. individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of study vaccine. 25. receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study. 26. receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination). 27. plan to travel outside the us (continental us, hawaii, and alaska) from enrollment through day 43. 28. history of surgery or major trauma within 12 weeks of screening, or surgery planned during the study. 29. significant blood loss (> 450 ml) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation. 30. strenuous activity (as assessed by the investigator) within 48 hours prior to dosing (days 1 and 22). 31. positive urine drugs of abuse or alcohol screen. 32. positive screen for hiv-1 and hiv-2 antibodies, hbsag, or hcv antibody. 33. involved in the planning or conduct of this study. 34. unwilling or unlikely to comply with the requirements of the study. 35. subject is an employee, contractor, friend of or relative of any employee of sponsor, cro, study site or site affiliate.

1. history of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. chronic condition that are not included on the cdc's list of subjects at higher risk for severe illness from sars-cov-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (day 1), with no medication changes, and no hospitalization in the past 6 months). 2. history of any medical conditions that place subjects at higher risk for severe illness due to sars-cov-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, severe obesity. 3. history of ongoing clinical condition or medication or treatments that may adversely affect the immune system. 4. individuals who are seropositive or rt-pcr positive for sars-cov-2 at screening. 5. individuals who are rt-pcr positive for sars-cov-2 at screening or prior to second dose of tap-covid-19 vaccine. 6. individuals who are at increased risk of exposure to sars-cov-2 (eg, healthcare workers, emergency responders). 7. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. 8. living in a group care facility (eg, assisted living or nursing home). 9. individuals with any elevated (grade 1 or higher) laboratory test assessed as clinically significant for age by the investigator at screening. 10. individuals with any elevated (grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). 11. active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "active" is defined as having received treatment within the past 5 years. 12. long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed). 13. history of autoimmune or inflammatory disease. 14. women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization. 15. history of guillain-barré syndrome. 16. history of anaphylactic-type reaction to injected vaccines. 17. known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal. 18. history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening. 19. acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator). 20. individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study. 21. receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study. 22. individuals who intend to donate blood within 6 months after the first vaccination. 23. individuals using prescription medications for prophylaxis of sars-cov-2. 24. individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of study vaccine. 25. receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study. 26. receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination). 27. plan to travel outside the us (continental us, hawaii, and alaska) from enrollment through day 43. 28. history of surgery or major trauma within 12 weeks of screening, or surgery planned during the study. 29. significant blood loss (> 450 ml) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation. 30. strenuous activity (as assessed by the investigator) within 48 hours prior to dosing (days 1 and 22). 31. positive urine drugs of abuse or alcohol screen. 32. positive screen for hiv-1 and hiv-2 antibodies, hbsag, or hcv antibody. 33. involved in the planning or conduct of this study. 34. unwilling or unlikely to comply with the requirements of the study. 35. subject is an employee, contractor, friend of or relative of any employee of sponsor, cro, study site or site affiliate.

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

1. history of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. chronic condition that are not included on the cdc's list of subjects at higher risk for severe illness from sars-cov-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (day 1), with no medication changes, and no hospitalization in the past 6 months). 2. history of any medical conditions that place subjects at higher risk for severe illness due to sars-cov-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, severe obesity. 3. history of ongoing clinical condition or medication or treatments that may adversely affect the immune system. 4. individuals who are seropositive or rt-pcr positive for sars-cov-2 at screening. 5. individuals who are at increased risk of exposure to sars-cov-2 (eg, healthcare workers, emergency responders). 6. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. 7. living in a group care facility (eg, assisted living or nursing home). 8. individuals with any elevated (grade 1 or higher) laboratory test assessed as clinically significant for age by the investigator at screening. 9. individuals with any elevated (grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). 10. active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "active" is defined as having received treatment within the past 5 years. 11. long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed). 12. history of autoimmune or inflammatory disease. 13. women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization. 14. history of guillain-barré syndrome. 15. history of anaphylactic-type reaction to injected vaccines. 16. known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal. 17. history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening. 18. acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator). 19. individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study. 20. receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study. 21. individuals who intend to donate blood within 6 months after the first vaccination. 22. individuals using prescription medications for prophylaxis of sars-cov-2. 23. individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of study vaccine. 24. receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study. 25. receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination). 26. plan to travel outside the us (continental us, hawaii, and alaska) from enrollment through day 43. 27. history of surgery or major trauma within 12 weeks of screening, or surgery planned during the study. 28. significant blood loss (> 450 ml) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation. 29. strenuous activity (as assessed by the investigator) within 48 hours prior to dosing (days 1 and 22). 30. positive urine drugs of abuse or alcohol screen. 31. positive screen for hiv-1 and hiv-2 antibodies, hbsag, or hcv antibody. 32. involved in the planning or conduct of this study. 33. unwilling or unlikely to comply with the requirements of the study.

1. history of an acute or chronic medical condition including dementia that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. chronic condition that are not included on the cdc's list of subjects at higher risk for severe illness from sars-cov-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (day 1), with no medication changes, and no hospitalization in the past 6 months). 2. history of any medical conditions that place subjects at higher risk for severe illness due to sars-cov-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, severe obesity. 3. history of ongoing clinical condition or medication or treatments that may adversely affect the immune system. 4. individuals who are seropositive or rt-pcr positive for sars-cov-2 at screening. 5. individuals who are at increased risk of exposure to sars-cov-2 (eg, healthcare workers, emergency responders). 6. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. 7. living in a group care facility (eg, assisted living or nursing home). 8. individuals with any elevated (grade 1 or higher) laboratory test assessed as clinically significant for age by the investigator at screening. 9. individuals with any elevated (grade 1 or higher) liver function enzyme at screening, regardless of the appraisal of clinical significance (cannot be retested to qualify for study). 10. active neoplastic disease (excluding nonmelanoma skin cancer that was successfully treated) or a history of any hematological malignancy. "active" is defined as having received treatment within the past 5 years. 11. long-term (greater than 2 weeks) use of oral or parenteral steroids or high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) within 6 months before screening (nasal and topical steroids are allowed). 12. history of autoimmune or inflammatory disease. 13. women currently pregnant, lactating, or planning a pregnancy between enrollment and 181 days after randomization. 14. history of guillain-barré syndrome. 15. history of anaphylactic-type reaction to injected vaccines. 16. known or suspected hypersensitivity to 1 or more of the components of the vaccine, including thimerosal. 17. history of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of screening. 18. acute illness or fever within 3 days before study enrollment (enrollment may be delayed for full recovery if acceptable to the investigator). 19. individuals currently participating or planning to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, or medication); or who have received an experimental agent within 1 month (3 months for immunoglobulins) before enrollment in this study; or who expect to receive another experimental agent during participation in this study. 20. receipt of immunoglobulin or another blood product within the 3 months before enrollment in this study or those who expect to receive immunoglobulin or another blood product during this study. 21. individuals who intend to donate blood within 6 months after the first vaccination. 22. individuals using prescription medications for prophylaxis of sars-cov-2. 23. individuals who plan to receive another vaccine within the first 3 months of the study except influenza vaccine which should not be given within 2 weeks of study vaccine. 24. receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study. 25. receipt of any investigational vaccine or drug within 1 month of enrollment and through the end of the study (1 year after first vaccination). 26. plan to travel outside the us (continental us, hawaii, and alaska) from enrollment through day 43. 27. history of surgery or major trauma within 12 weeks of screening, or surgery planned during the study. 28. significant blood loss (> 450 ml) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation. 29. strenuous activity (as assessed by the investigator) within 48 hours prior to dosing (days 1 and 22). 30. positive urine drugs of abuse or alcohol screen. 31. positive screen for hiv-1 and hiv-2 antibodies, hbsag, or hcv antibody. 32. involved in the planning or conduct of this study. 33. unwilling or unlikely to comply with the requirements of the study.