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

participants are excluded from the study if any of the following criteria apply: prior/concomitant therapy * receipt of, or planned receipt of a covid-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of sars-cov-2 infection or treatment of covid-19. * note: for study participants who become hospitalised with covid-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted. * receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). outside these periods, other routine vaccinations are permitted as clinically indicated. * medical conditions * hypersensitivity to the active substance or to any of the excipients listed in section 6.1. * the participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study. * additional details are described in section 5.2.1. * individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia. * clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture. * history of guillain-barré syndrome. * any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia. * 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). * 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. * note: the aesis as outlined in the csp should be considered when evaluating a participant for this exclusion criteria as the presence of these aesis, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data. * other criteria * current participation in any other research studies that would interfere with the objectives of this study. the determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.

participants are excluded from the study if any of the following criteria apply: prior/concomitant therapy * receipt of, or planned receipt of a covid-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of sars-cov-2 infection or treatment of covid-19. * note: for study participants who become hospitalised with covid-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted. * receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). outside these periods, other routine vaccinations are permitted as clinically indicated. * medical conditions * hypersensitivity to the active substance or to any of the excipients listed in section 6.1. * the participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study. * additional details are described in section 5.2.1. * individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia. * clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture. * history of guillain-barré syndrome. * any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia. * 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). * 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. * note: the aesis as outlined in the csp should be considered when evaluating a participant for this exclusion criteria as the presence of these aesis, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data. * other criteria * current participation in any other research studies that would interfere with the objectives of this study. the determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.

Feb. 13, 2023, 8:44 a.m. usa

participants are excluded from the study if any of the following criteria apply: prior/concomitant therapy receipt of, or planned receipt of a covid-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of sars-cov-2 infection or treatment of covid-19. note: for study participants who become hospitalised with covid-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted. receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). outside these periods, other routine vaccinations are permitted as clinically indicated. medical conditions hypersensitivity to the active substance or to any of the excipients listed in section 6.1. the participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study. additional details are described in section 5.2.1. individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture. history of guillain-barré syndrome. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia. 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). 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. note: the aesis as outlined in the csp should be considered when evaluating a participant for this exclusion criteria as the presence of these aesis, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data. other criteria current participation in any other research studies that would interfere with the objectives of this study. the determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.

participants are excluded from the study if any of the following criteria apply: prior/concomitant therapy receipt of, or planned receipt of a covid-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of sars-cov-2 infection or treatment of covid-19. note: for study participants who become hospitalised with covid-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted. receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). outside these periods, other routine vaccinations are permitted as clinically indicated. medical conditions hypersensitivity to the active substance or to any of the excipients listed in section 6.1. the participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study. additional details are described in section 5.2.1. individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia. clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture. history of guillain-barré syndrome. any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia. 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). 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. note: the aesis as outlined in the csp should be considered when evaluating a participant for this exclusion criteria as the presence of these aesis, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data. other criteria current participation in any other research studies that would interfere with the objectives of this study. the determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.