Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

history of allergy to any component of the vaccine history of guillain-barré syndrome or any other demyelinating condition significant infection or other acute illness, including fever > 37.3 °c on the day prior to or day of randomization history of laboratory-confirmed sars-cov-2 infection any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase ii) recurrent severe infections and use of immunosuppressant medication within the past 6 months history of primary malignancy except for: (a) malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) adequately treated uterine cervical carcinoma in situ without evidence of disease (d) localized prostate cancer (only for phase ii) clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or vene puncture severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase ii) any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of sars-cov-2 or covid-19 receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up involvement in the planning and/or conduct of this study (applies to both sponsor staff and/or staff at the study site) for women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding has donated ≥ 450 ml of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.

history of allergy to any component of the vaccine history of guillain-barré syndrome or any other demyelinating condition significant infection or other acute illness, including fever > 37.3 °c on the day prior to or day of randomization history of laboratory-confirmed sars-cov-2 infection any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase ii) recurrent severe infections and use of immunosuppressant medication within the past 6 months history of primary malignancy except for: (a) malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) adequately treated uterine cervical carcinoma in situ without evidence of disease (d) localized prostate cancer (only for phase ii) clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or vene puncture severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase ii) any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of sars-cov-2 or covid-19 receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up involvement in the planning and/or conduct of this study (applies to both sponsor staff and/or staff at the study site) for women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding has donated ≥ 450 ml of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.

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

1. history of allergy to any component of the vaccine 2. history of guillain-barré syndrome or any other demyelinating condition 3. significant infection or other acute illness, including fever > 37.3 °c on the day prior to or day of randomization 4. history of laboratory-confirmed sars-cov-2 infection 5. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase ii) 6. recurrent severe infections and use of immunosuppressant medication within the past 6 months 7. history of primary malignancy except for: (a) malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) adequately treated uterine cervical carcinoma in situ without evidence of disease (d) localized prostate cancer (only for phase ii) 8. clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or vene puncture 9. severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase ii) 10. any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data 11. receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of sars-cov-2 or covid-19 12. receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention 13. receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up 14. involvement in the planning and/or conduct of this study (applies to both sponsor staff and/or staff at the study site) 15. for women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding 16. has donated ≥ 450 ml of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.

1. history of allergy to any component of the vaccine 2. history of guillain-barré syndrome or any other demyelinating condition 3. significant infection or other acute illness, including fever > 37.3 °c on the day prior to or day of randomization 4. history of laboratory-confirmed sars-cov-2 infection 5. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase ii) 6. recurrent severe infections and use of immunosuppressant medication within the past 6 months 7. history of primary malignancy except for: (a) malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) adequately treated uterine cervical carcinoma in situ without evidence of disease (d) localized prostate cancer (only for phase ii) 8. clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following im injections or vene puncture 9. severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase ii) 10. any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data 11. receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of sars-cov-2 or covid-19 12. receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention 13. receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up 14. involvement in the planning and/or conduct of this study (applies to both sponsor staff and/or staff at the study site) 15. for women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding 16. has donated ≥ 450 ml of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.