Created at Source Raw Value Validated value
March 27, 2022, 4 p.m. usa

None

None

Oct. 26, 2021, 11 a.m. usa

- has prior or planned administration of a coronavirus vaccine (for example, sars-cov-2 [for unvaccinated participants only], sars-cov, or mers [middle east respiratory syndrome] -cov vaccine). - has current treatment with investigational agents for either prophylaxis against covid-19 (for unvaccinated participants only) or treatment of covid-19 (such as, anti-sars-cov-2 monoclonal antibodies). - a history of more than one solid organ transplanted (such as, kidney and pancreas). a history of previous kidney or liver transplant is acceptable. - has received therapies that have depleting properties on t cells, b cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [atg], monoclonal antibodies, and proteosome inhibitors) within the last 6 months prior to enrollment. - a history of biopsy-proven t-cell- or ab-mediated rejection within 6 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment. - has a known close contact with anyone with laboratory confirmed sars-cov-2 infection within 2 weeks to vaccine administration or known history of sars-cov-2 infection or positive sars-cov-2 test. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has a history of clinically relevant donor-specific ab according to the judgement of the investigator. - has a history of complications of immunosuppression - suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment - known human immunodeficiency virus (hiv) infection - has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to day 1. - participated in an interventional clinical study within 28 days prior to day 0 or plans to donate blood products while participating in this study. healthy participants key inclusion criteria : - in good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent, and has not been vaccinated with any covid-19 vaccine at the time of consent. - understands and agrees to comply with the study procedures and provides written informed consent. - is able to comply with study procedures based on the assessment of the investigator. - for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding. - is medically stable, according to investigator's judgment, during the 3 months before signing consent. key

- has prior or planned administration of a coronavirus vaccine (for example, sars-cov-2 [for unvaccinated participants only], sars-cov, or mers [middle east respiratory syndrome] -cov vaccine). - has current treatment with investigational agents for either prophylaxis against covid-19 (for unvaccinated participants only) or treatment of covid-19 (such as, anti-sars-cov-2 monoclonal antibodies). - a history of more than one solid organ transplanted (such as, kidney and pancreas). a history of previous kidney or liver transplant is acceptable. - has received therapies that have depleting properties on t cells, b cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [atg], monoclonal antibodies, and proteosome inhibitors) within the last 6 months prior to enrollment. - a history of biopsy-proven t-cell- or ab-mediated rejection within 6 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment. - has a known close contact with anyone with laboratory confirmed sars-cov-2 infection within 2 weeks to vaccine administration or known history of sars-cov-2 infection or positive sars-cov-2 test. - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has a history of clinically relevant donor-specific ab according to the judgement of the investigator. - has a history of complications of immunosuppression - suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment - known human immunodeficiency virus (hiv) infection - has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to day 1. - participated in an interventional clinical study within 28 days prior to day 0 or plans to donate blood products while participating in this study. healthy participants key inclusion criteria : - in good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent, and has not been vaccinated with any covid-19 vaccine at the time of consent. - understands and agrees to comply with the study procedures and provides written informed consent. - is able to comply with study procedures based on the assessment of the investigator. - for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding. - is medically stable, according to investigator's judgment, during the 3 months before signing consent. key

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

- a history of more than one solid organ transplanted (such as, kidney and pancreas). a history of previous kidney or liver transplant is acceptable. - has received therapies that have depleting properties on t cells, b cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [atg], monoclonal antibodies, and proteosome inhibitors) within the last 6 months prior to enrollment. - a history of biopsy-proven t-cell- or ab-mediated rejection within 6 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment. - has a known close contact with anyone with laboratory confirmed sars-cov-2 infection within 2 weeks to vaccine administration or known history of sars-cov-2 infection or positive sars-cov-2 test. - has current treatment with investigational agents for either prophylaxis against covid-19 or treatment of covid-19 (such as, anti-sars-cov-2 monoclonal antibodies). - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has a history of clinically relevant donor-specific ab according to the judgement of the investigator. - has a history of complications of immunosuppression - suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment - known human immunodeficiency virus (hiv) infection - has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to day 1. - participated in an interventional clinical study within 28 days prior to day 0 or plans to donate blood products while participating in this study. healthy participants key inclusion criteria : - in good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent - understands and agrees to comply with the study procedures and provides written informed consent. - is able to comply with study procedures based on the assessment of the investigator. - for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding. - is medically stable, according to investigator's judgment, during the 3 months before signing consent. key

- a history of more than one solid organ transplanted (such as, kidney and pancreas). a history of previous kidney or liver transplant is acceptable. - has received therapies that have depleting properties on t cells, b cells, and plasma cells (examples of depletional therapies include, but are not limited to, antithymocyte globulin [atg], monoclonal antibodies, and proteosome inhibitors) within the last 6 months prior to enrollment. - a history of biopsy-proven t-cell- or ab-mediated rejection within 6 months of informed consent, or suspected active or chronic rejection according to the investigator's judgment. - has a known close contact with anyone with laboratory confirmed sars-cov-2 infection within 2 weeks to vaccine administration or known history of sars-cov-2 infection or positive sars-cov-2 test. - has current treatment with investigational agents for either prophylaxis against covid-19 or treatment of covid-19 (such as, anti-sars-cov-2 monoclonal antibodies). - has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. - has a history of clinically relevant donor-specific ab according to the judgement of the investigator. - has a history of complications of immunosuppression - suspected clinically relevant active hepatitis, including viral hepatitis, according to the investigator's judgment - known human immunodeficiency virus (hiv) infection - has a history of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. - received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine) - received intravenous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to day 1. - participated in an interventional clinical study within 28 days prior to day 0 or plans to donate blood products while participating in this study. healthy participants key inclusion criteria : - in good general health without current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition, according to investigator assessment, at the time of consent - understands and agrees to comply with the study procedures and provides written informed consent. - is able to comply with study procedures based on the assessment of the investigator. - for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding. - is medically stable, according to investigator's judgment, during the 3 months before signing consent. key