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

1. received any other sars-cov-2 vaccination than a single janssen ad26.cov2.s vaccine or plans to receive any additional sars-cov-2 vaccination within 90 days after the study vaccine (day 1). 2. recovered from sars-cov-2 infection determined by history of a positive sars-cov-2 test (e.g. pcr, rapid antigen test, etc.) or suspicion of a sars-cov-2 infection based on the (verbal) medical history within less than 60 days from the day of vaccination (day 1) in this study. 3. history of close contact (face-to-face contact within 1 meter or contact in a closed space for more than 15 minutes) without wearing a face-mask with a confirmed active sars-cov-2-positive patient within 5 days prior to day 1. 4. have received any live-virus vaccine within 4 weeks or inactivated vaccine, including influenza vaccine, within 2 weeks (both licensed and investigational vaccines) prior to the study vaccine (day 1). 5. previous participation in any clinical trial of a sars-cov-2 vaccine candidate. 6. have any febrile illness (temperature ≥ 38°c/100.4°f) or any active acute illness or infection (including a positive sars-cov-2 pcr test) within 7 days prior to administration of vaccination (day 1) in this study. participants may be re-evaluated once all symptoms have resolved. 7. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) or contraindications to any component of the study intervention(s). 8. history of, or positive screening test for human immunodeficiency virus i or ii. 9. any clinically significant finding during screening or check-in that, in the investigator's judgment, results in an increased safety risk. 10. history of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (hitt or hit type 2). 11. any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 3 months, except topical and inhaled steroids, or short-term oral steroids (course lasting ≤14 days or ≤20 mg/day). 12. history of receiving blood transfusion, blood products, immunoglobulin, or immune stimulants within 3 months prior to day 1. 13. is currently participating in any other study or has received any investigational drug in the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior to screening. 14. for female participants of childbearing potential who are pregnant (positive pregnancy test at the screening or check-in), currently breastfeeding, or attempting to conceive. 15. any addiction that may interfere with the participant's ability to comply with trial procedures. 16. inability to be venipunctured or tolerate venous, im, sc, or id puncture. 17. have a rash, dermatological condition, tattoo, or any other abnormality at the injection site that may interfere with injection site reaction rating. investigator discretion will be permitted with this exclusion criterion. 18. use of prophylactic medications (e.g., antihistamines \[h1 receptor antagonists\], nonsteroidal anti-inflammatory drugs \[nsaids\], systemic glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-empt symptoms due to vaccination. 19. any condition or abnormal baseline findings or any other unspecified reason, which in the investigator's judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objective of the study. 20. participants identified as an investigator or employee of the investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator, or employee with direct involvement in the proposed study, or any employees of the sponsor company.

1. received any other sars-cov-2 vaccination than a single janssen ad26.cov2.s vaccine or plans to receive any additional sars-cov-2 vaccination within 90 days after the study vaccine (day 1). 2. recovered from sars-cov-2 infection determined by history of a positive sars-cov-2 test (e.g. pcr, rapid antigen test, etc.) or suspicion of a sars-cov-2 infection based on the (verbal) medical history within less than 60 days from the day of vaccination (day 1) in this study. 3. history of close contact (face-to-face contact within 1 meter or contact in a closed space for more than 15 minutes) without wearing a face-mask with a confirmed active sars-cov-2-positive patient within 5 days prior to day 1. 4. have received any live-virus vaccine within 4 weeks or inactivated vaccine, including influenza vaccine, within 2 weeks (both licensed and investigational vaccines) prior to the study vaccine (day 1). 5. previous participation in any clinical trial of a sars-cov-2 vaccine candidate. 6. have any febrile illness (temperature ≥ 38°c/100.4°f) or any active acute illness or infection (including a positive sars-cov-2 pcr test) within 7 days prior to administration of vaccination (day 1) in this study. participants may be re-evaluated once all symptoms have resolved. 7. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) or contraindications to any component of the study intervention(s). 8. history of, or positive screening test for human immunodeficiency virus i or ii. 9. any clinically significant finding during screening or check-in that, in the investigator's judgment, results in an increased safety risk. 10. history of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (hitt or hit type 2). 11. any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 3 months, except topical and inhaled steroids, or short-term oral steroids (course lasting ≤14 days or ≤20 mg/day). 12. history of receiving blood transfusion, blood products, immunoglobulin, or immune stimulants within 3 months prior to day 1. 13. is currently participating in any other study or has received any investigational drug in the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior to screening. 14. for female participants of childbearing potential who are pregnant (positive pregnancy test at the screening or check-in), currently breastfeeding, or attempting to conceive. 15. any addiction that may interfere with the participant's ability to comply with trial procedures. 16. inability to be venipunctured or tolerate venous, im, sc, or id puncture. 17. have a rash, dermatological condition, tattoo, or any other abnormality at the injection site that may interfere with injection site reaction rating. investigator discretion will be permitted with this exclusion criterion. 18. use of prophylactic medications (e.g., antihistamines \[h1 receptor antagonists\], nonsteroidal anti-inflammatory drugs \[nsaids\], systemic glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-empt symptoms due to vaccination. 19. any condition or abnormal baseline findings or any other unspecified reason, which in the investigator's judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objective of the study. 20. participants identified as an investigator or employee of the investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator, or employee with direct involvement in the proposed study, or any employees of the sponsor company.

May 8, 2023, midnight usa

received any other sars-cov-2 vaccination than a single janssen ad26.cov2.s vaccine or plans to receive any additional sars-cov-2 vaccination within 90 days after the study vaccine (day 1). recovered from sars-cov-2 infection determined by history of a positive sars-cov-2 test (e.g. pcr, rapid antigen test, etc.) or suspicion of a sars-cov-2 infection based on the (verbal) medical history within less than 60 days from the day of vaccination (day 1) in this study. history of close contact (face-to-face contact within 1 meter or contact in a closed space for more than 15 minutes) without wearing a face-mask with a confirmed active sars-cov-2-positive patient within 5 days prior to day 1. have received any live-virus vaccine within 4 weeks or inactivated vaccine, including influenza vaccine, within 2 weeks (both licensed and investigational vaccines) prior to the study vaccine (day 1). previous participation in any clinical trial of a sars-cov-2 vaccine candidate. have any febrile illness (temperature ≥ 38°c/100.4°f) or any active acute illness or infection (including a positive sars-cov-2 pcr test) within 7 days prior to administration of vaccination (day 1) in this study. participants may be re-evaluated once all symptoms have resolved. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) or contraindications to any component of the study intervention(s). history of, or positive screening test for human immunodeficiency virus i or ii. any clinically significant finding during screening or check-in that, in the investigator's judgment, results in an increased safety risk. history of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (hitt or hit type 2). any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 3 months, except topical and inhaled steroids, or short-term oral steroids (course lasting ≤14 days or ≤20 mg/day). history of receiving blood transfusion, blood products, immunoglobulin, or immune stimulants within 3 months prior to day 1. is currently participating in any other study or has received any investigational drug in the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior to screening. for female participants of childbearing potential who are pregnant (positive pregnancy test at the screening or check-in), currently breastfeeding, or attempting to conceive. any addiction that may interfere with the participant's ability to comply with trial procedures. inability to be venipunctured or tolerate venous, im, sc, or id puncture. have a rash, dermatological condition, tattoo, or any other abnormality at the injection site that may interfere with injection site reaction rating. investigator discretion will be permitted with this exclusion criterion. use of prophylactic medications (e.g., antihistamines [h1 receptor antagonists], nonsteroidal anti-inflammatory drugs [nsaids], systemic glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-empt symptoms due to vaccination. any condition or abnormal baseline findings or any other unspecified reason, which in the investigator's judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objective of the study. participants identified as an investigator or employee of the investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator, or employee with direct involvement in the proposed study, or any employees of the sponsor company.

received any other sars-cov-2 vaccination than a single janssen ad26.cov2.s vaccine or plans to receive any additional sars-cov-2 vaccination within 90 days after the study vaccine (day 1). recovered from sars-cov-2 infection determined by history of a positive sars-cov-2 test (e.g. pcr, rapid antigen test, etc.) or suspicion of a sars-cov-2 infection based on the (verbal) medical history within less than 60 days from the day of vaccination (day 1) in this study. history of close contact (face-to-face contact within 1 meter or contact in a closed space for more than 15 minutes) without wearing a face-mask with a confirmed active sars-cov-2-positive patient within 5 days prior to day 1. have received any live-virus vaccine within 4 weeks or inactivated vaccine, including influenza vaccine, within 2 weeks (both licensed and investigational vaccines) prior to the study vaccine (day 1). previous participation in any clinical trial of a sars-cov-2 vaccine candidate. have any febrile illness (temperature ≥ 38°c/100.4°f) or any active acute illness or infection (including a positive sars-cov-2 pcr test) within 7 days prior to administration of vaccination (day 1) in this study. participants may be re-evaluated once all symptoms have resolved. history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) or contraindications to any component of the study intervention(s). history of, or positive screening test for human immunodeficiency virus i or ii. any clinically significant finding during screening or check-in that, in the investigator's judgment, results in an increased safety risk. history of cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (hitt or hit type 2). any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 3 months, except topical and inhaled steroids, or short-term oral steroids (course lasting ≤14 days or ≤20 mg/day). history of receiving blood transfusion, blood products, immunoglobulin, or immune stimulants within 3 months prior to day 1. is currently participating in any other study or has received any investigational drug in the last 6 weeks or 5× the half-life of the drug (whichever is longer) prior to screening. for female participants of childbearing potential who are pregnant (positive pregnancy test at the screening or check-in), currently breastfeeding, or attempting to conceive. any addiction that may interfere with the participant's ability to comply with trial procedures. inability to be venipunctured or tolerate venous, im, sc, or id puncture. have a rash, dermatological condition, tattoo, or any other abnormality at the injection site that may interfere with injection site reaction rating. investigator discretion will be permitted with this exclusion criterion. use of prophylactic medications (e.g., antihistamines [h1 receptor antagonists], nonsteroidal anti-inflammatory drugs [nsaids], systemic glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the vaccination to prevent or pre-empt symptoms due to vaccination. any condition or abnormal baseline findings or any other unspecified reason, which in the investigator's judgment might increase the risk to the participant or decrease the chance of obtaining satisfactory data needed to achieve the objective of the study. participants identified as an investigator or employee of the investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the investigator, or employee with direct involvement in the proposed study, or any employees of the sponsor company.