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

history of allergy to any component of azd1222/azd2816. history of guillain-barré syndrome, any demyelinating disease, or any other neuroimmunologic condition significant infection or other acute illness, including fever > 100 °f (> 37.8 °c) on the day prior to or day of randomization any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or hiv/aids. recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). the following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days) history of primary malignancy (see protocol) history of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any covid-19 vaccine history of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor v leiden, prothrombin g20210a, antithrombin iii deficiency, protein c deficiency and protein s deficiency, factor xiii mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the investigator 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 any autoimmune conditions, except mild psoriasis and vitiligo.

history of allergy to any component of azd1222/azd2816. history of guillain-barré syndrome, any demyelinating disease, or any other neuroimmunologic condition significant infection or other acute illness, including fever > 100 °f (> 37.8 °c) on the day prior to or day of randomization any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or hiv/aids. recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). the following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days) history of primary malignancy (see protocol) history of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any covid-19 vaccine history of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor v leiden, prothrombin g20210a, antithrombin iii deficiency, protein c deficiency and protein s deficiency, factor xiii mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the investigator 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 any autoimmune conditions, except mild psoriasis and vitiligo.

July 23, 2021, 10:30 p.m. usa

1. history of allergy to any component of azd1222/azd2816. 2. history of guillain-barré syndrome, any demyelinating disease, or any other neuroimmunologic condition 3. significant infection or other acute illness, including fever > 100 °f (> 37.8 °c) on the day prior to or day of randomization 4. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or hiv/aids. 5. recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). the following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days) 6. history of primary malignancy (see protocol) 7. history of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any covid-19 vaccine 8. history of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor v leiden, prothrombin g20210a, antithrombin iii deficiency, protein c deficiency and protein s deficiency, factor xiii mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. 9. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture 10. severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the investigator 11. 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 12. any autoimmune conditions, except mild psoriasis and vitiligo.

1. history of allergy to any component of azd1222/azd2816. 2. history of guillain-barré syndrome, any demyelinating disease, or any other neuroimmunologic condition 3. significant infection or other acute illness, including fever > 100 °f (> 37.8 °c) on the day prior to or day of randomization 4. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or hiv/aids. 5. recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). the following exceptions are permitted: topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days) 6. history of primary malignancy (see protocol) 7. history of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any covid-19 vaccine 8. history of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor v leiden, prothrombin g20210a, antithrombin iii deficiency, protein c deficiency and protein s deficiency, factor xiii mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. 9. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture 10. severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the investigator 11. 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 12. any autoimmune conditions, except mild psoriasis and vitiligo.