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

medical conditions * individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. * nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. * close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. * individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). * any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. * family history of congenital/hereditary immunodeficiency. * history of or current autoimmune disease. * history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. * history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. * lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). * history of recurrent anemia within the last 6 months. * hypersensitivity to latex. * any acute/chronic, clinically significant disease the following conditions will be exclusionary: * diabetes mellitus (type i or ii), with exception of gestational diabetes. * respiratory disease such as: * chronic pulmonary diseases, * bronchopulmonary dysplasia, * uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. * significant and/or uncontrolled psychiatric illness: * hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, * clinically significant depression. * major neurological disease including: * seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), * myasthenia gravis, * history of repetitive migraine mal/status migrainosus. * significant cardiovascular disease, including: * uncontrolled arterial hypertension, * congenital heart disease, * previous myocardial infarction, * valvular heart disease or history of rheumatic fever, * previous bacterial endocarditis, * history of cardiac surgery, * personal/ family history of cardiomyopathy/sudden adult death. * asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. * hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. * history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. * idiopathic urticaria within the past year. * any other significant uncontrolled medical illness within 3 months prior to study intervention administration. * acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. * participants with a minor illness without fever may be enrolled. * any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy * use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. * planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered \>15 days before/after vaccination. * planned administration/administration of an emergency use authorization vaccine against sars-cov-2 in the period starting prior to the first dose of study intervention and ending 15 days after the second dose of study intervention * administration of long-acting immune-modifying drugs at any time during the study * administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. * chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent \>10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience * receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study * concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions * pregnant/lactating female * female planning to become pregnant/planning to discontinue contraceptive precautions * alcohol and/or drug abuse. * current/history of chronic tobacco/marijuana smoking/vaping. * participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

medical conditions * individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. * nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. * close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. * individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). * any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. * family history of congenital/hereditary immunodeficiency. * history of or current autoimmune disease. * history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. * history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. * lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). * history of recurrent anemia within the last 6 months. * hypersensitivity to latex. * any acute/chronic, clinically significant disease the following conditions will be exclusionary: * diabetes mellitus (type i or ii), with exception of gestational diabetes. * respiratory disease such as: * chronic pulmonary diseases, * bronchopulmonary dysplasia, * uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. * significant and/or uncontrolled psychiatric illness: * hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, * clinically significant depression. * major neurological disease including: * seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), * myasthenia gravis, * history of repetitive migraine mal/status migrainosus. * significant cardiovascular disease, including: * uncontrolled arterial hypertension, * congenital heart disease, * previous myocardial infarction, * valvular heart disease or history of rheumatic fever, * previous bacterial endocarditis, * history of cardiac surgery, * personal/ family history of cardiomyopathy/sudden adult death. * asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. * hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. * history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. * idiopathic urticaria within the past year. * any other significant uncontrolled medical illness within 3 months prior to study intervention administration. * acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. * participants with a minor illness without fever may be enrolled. * any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy * use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. * planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered \>15 days before/after vaccination. * planned administration/administration of an emergency use authorization vaccine against sars-cov-2 in the period starting prior to the first dose of study intervention and ending 15 days after the second dose of study intervention * administration of long-acting immune-modifying drugs at any time during the study * administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. * chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent \>10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience * receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study * concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions * pregnant/lactating female * female planning to become pregnant/planning to discontinue contraceptive precautions * alcohol and/or drug abuse. * current/history of chronic tobacco/marijuana smoking/vaping. * participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

June 23, 2021, 1:30 a.m. usa

medical conditions - individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. - nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. - close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. - individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). - any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. - family history of congenital/hereditary immunodeficiency. - history of or current autoimmune disease. - history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. - history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. - lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). - history of recurrent anemia within the last 6 months. - hypersensitivity to latex. - any acute/chronic, clinically significant disease the following conditions will be exclusionary: - diabetes mellitus (type i or ii), with exception of gestational diabetes. - respiratory disease such as: - chronic pulmonary diseases, - bronchopulmonary dysplasia, - uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. - significant and/or uncontrolled psychiatric illness: - hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, - clinically significant depression. - major neurological disease including: - seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), - myasthenia gravis, - history of repetitive migraine mal/status migrainosus. - significant cardiovascular disease, including: - uncontrolled arterial hypertension, - congenital heart disease, - previous myocardial infarction, - valvular heart disease or history of rheumatic fever, - previous bacterial endocarditis, - history of cardiac surgery, - personal/ family history of cardiomyopathy/sudden adult death. - asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. - hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. - history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. - idiopathic urticaria within the past year. - any other significant uncontrolled medical illness within 3 months prior to study intervention administration. - acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. - participants with a minor illness without fever may be enrolled. - any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy - use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. - planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered >15 days before/after vaccination. - planned administration/administration of an emergency use authorization vaccine against sars-cov-2 in the period starting prior to the first dose of study intervention and ending 15 days after the second dose of study intervention - administration of long-acting immune-modifying drugs at any time during the study - administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. - chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent >10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study - concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions - pregnant/lactating female - female planning to become pregnant/planning to discontinue contraceptive precautions - alcohol and/or drug abuse. - current/history of chronic tobacco/marijuana smoking/vaping. - participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

medical conditions - individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. - nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. - close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. - individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). - any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. - family history of congenital/hereditary immunodeficiency. - history of or current autoimmune disease. - history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. - history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. - lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). - history of recurrent anemia within the last 6 months. - hypersensitivity to latex. - any acute/chronic, clinically significant disease the following conditions will be exclusionary: - diabetes mellitus (type i or ii), with exception of gestational diabetes. - respiratory disease such as: - chronic pulmonary diseases, - bronchopulmonary dysplasia, - uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. - significant and/or uncontrolled psychiatric illness: - hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, - clinically significant depression. - major neurological disease including: - seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), - myasthenia gravis, - history of repetitive migraine mal/status migrainosus. - significant cardiovascular disease, including: - uncontrolled arterial hypertension, - congenital heart disease, - previous myocardial infarction, - valvular heart disease or history of rheumatic fever, - previous bacterial endocarditis, - history of cardiac surgery, - personal/ family history of cardiomyopathy/sudden adult death. - asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. - hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. - history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. - idiopathic urticaria within the past year. - any other significant uncontrolled medical illness within 3 months prior to study intervention administration. - acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. - participants with a minor illness without fever may be enrolled. - any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy - use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. - planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered >15 days before/after vaccination. - planned administration/administration of an emergency use authorization vaccine against sars-cov-2 in the period starting prior to the first dose of study intervention and ending 15 days after the second dose of study intervention - administration of long-acting immune-modifying drugs at any time during the study - administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. - chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent >10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study - concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions - pregnant/lactating female - female planning to become pregnant/planning to discontinue contraceptive precautions - alcohol and/or drug abuse. - current/history of chronic tobacco/marijuana smoking/vaping. - participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

Feb. 19, 2021, 12:31 a.m. usa

medical conditions - individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. - nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. - close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. - individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). - any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. - family history of congenital/hereditary immunodeficiency. - history of or current autoimmune disease. - history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. - history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. - lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). - history of recurrent anemia within the last 6 months. - hypersensitivity to latex. - any acute/chronic, clinically significant disease the following conditions will be exclusionary: - diabetes mellitus (type i or ii), with exception of gestational diabetes. - respiratory disease such as: - chronic pulmonary diseases, - bronchopulmonary dysplasia, - uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. - significant and/or uncontrolled psychiatric illness: - hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, - clinically significant depression. - major neurological disease including: - seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), - myasthenia gravis, - history of repetitive migraine mal/status migrainosus. - significant cardiovascular disease, including: - uncontrolled arterial hypertension, - congenital heart disease, - previous myocardial infarction, - valvular heart disease or history of rheumatic fever, - previous bacterial endocarditis, - history of cardiac surgery, - personal/ family history of cardiomyopathy/sudden adult death. - asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. - hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. - history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. - idiopathic urticaria within the past year. - any other significant uncontrolled medical illness within 3 months prior to study intervention administration. - acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. - participants with a minor illness without fever may be enrolled. - any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy - use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. - planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered >15 days before/after vaccination. - administration of long-acting immune-modifying drugs at any time during the study - administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. - chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent >10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study - concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions - pregnant/lactating female - female planning to become pregnant/planning to discontinue contraceptive precautions - alcohol and/or drug abuse. - current/history of chronic tobacco/marijuana smoking/vaping. - participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.

medical conditions - individuals with signs and symptoms consistent with covid-19, according to cdc guidelines and following clinical judgement. - nasal and/or oral swab positive for sars-cov-2 by rt-pcr within the last 30 days, unless participant has had a subsequent negative swab and is asymptomatic. - close contact (within 30 days prior to study intervention administration) with anyone known to have sars-cov-2 infection. - individuals currently working in occupations with high risk of exposure to sars-cov-2 (e.g., healthcare workers, emergency response personnel). - any confirmed or suspected immunosuppressive/immunodeficient condition based on medical history and physical examination. - family history of congenital/hereditary immunodeficiency. - history of or current autoimmune disease. - history of any reaction/hypersensitivity likely to be exacerbated by any components of the study intervention. - history of hypersensitivity/severe allergic reaction to any previous licensed/unlicensed vaccine. - lymphoproliferative disorder/malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer). - history of recurrent anemia within the last 6 months. - hypersensitivity to latex. - any acute/chronic, clinically significant disease the following conditions will be exclusionary: - diabetes mellitus (type i or ii), with exception of gestational diabetes. - respiratory disease such as: - chronic pulmonary diseases, - bronchopulmonary dysplasia, - uncontrolled asthma/asthma necessitating treatment with chronic systemic/inhaled glucocorticoids. - significant and/or uncontrolled psychiatric illness: - hospitalization for psychiatric illness, history of suicide attempts/confinement for danger to self/others within 5 years, - clinically significant depression. - major neurological disease including: - seizure or adulthood epilepsy (note: history of febrile convulsion in childhood is not exclusionary), - myasthenia gravis, - history of repetitive migraine mal/status migrainosus. - significant cardiovascular disease, including: - uncontrolled arterial hypertension, - congenital heart disease, - previous myocardial infarction, - valvular heart disease or history of rheumatic fever, - previous bacterial endocarditis, - history of cardiac surgery, - personal/ family history of cardiomyopathy/sudden adult death. - asplenia, functional asplenia/any condition resulting in the absence/removal of the spleen. - hereditary angioedema, acquired angioedema/ idiopathic forms of angioedema. - history of, or concurrent, autoimmune thyroid disease regardless of treatment and thyroid status as well as any uncontrolled thyroid disease. - idiopathic urticaria within the past year. - any other significant uncontrolled medical illness within 3 months prior to study intervention administration. - acute illness and/or fever at the time of screening. participants with acute illness and/ or fever at the time of screening may be re screened later. - participants with a minor illness without fever may be enrolled. - any other clinical condition that might pose additional risk to the participant due to participation in the study. prior/concomitant therapy - use of any investigational or non-registered product other than the study intervention(s) during the period beginning 45 days before the first dose (day -45 to day 1), or their planned use during the study. - planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the vaccination and ending 30 days after, with the exception of any licensed influenza vaccine which may be administered >15 days before/after vaccination. - administration of long-acting immune-modifying drugs at any time during the study - administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose until study end. - chronic administration of immunosuppressants/other immune-modifying drugs during the period starting 6 months prior to the first dose. for corticosteroids, this will mean prednisone equivalent >10 mg/day. topical steroids are allowed. prior/concurrent clinical study experience - receipt of any other sars-cov-2 or other experimental coronavirus vaccine at any time prior to or during the study - concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention other exclusions - pregnant/lactating female - female planning to become pregnant/planning to discontinue contraceptive precautions - alcohol and/or drug abuse. - current/history of chronic tobacco/marijuana smoking/vaping. - participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.