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

1. any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. * asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. * acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. * acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. 2. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. 3. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. 4. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 7. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. 8. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 9. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 12. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. 13. known disturbance of coagulation. 14. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 15. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \> 38.0°c, on the planned day of vaccine administration). 16. any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 17. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

1. any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. * asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. * acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. * acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. 2. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. 3. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. 4. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 7. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. 8. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 9. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 12. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. 13. known disturbance of coagulation. 14. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 15. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \> 38.0°c, on the planned day of vaccine administration). 16. any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 17. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

Nov. 16, 2021, 6:30 p.m. usa

any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. any history of anaphylaxis to any prior vaccine. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. any history of anaphylaxis to any prior vaccine. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

July 21, 2021, 4 p.m. usa

1. any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. - asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. - acute or chronic illnesses or condition which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. - acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. 2. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. 3. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. 4. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 7. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. 8. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 9. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 12. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. 13. known disturbance of coagulation. 14. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 15. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). 16. any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 17. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

1. any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. - asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. - acute or chronic illnesses or condition which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. - acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. 2. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. 3. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. 4. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 7. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. 8. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. 9. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. 10. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 11. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 12. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. 13. known disturbance of coagulation. 14. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 15. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). 16. any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 17. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

July 15, 2021, 6 a.m. usa

any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. acute or chronic illnesses or condition which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. any history of anaphylaxis to any prior vaccine. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).

any ongoing, symptomatic acute, or chronic illness requiring medical or surgical care. asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time-course of this study), in the opinion of the investigator. acute or chronic illnesses or condition which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza or sars-cov-2 infection (eg, cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable. participation in research involving an investigational product (drug/biologic/device) within 90 days before the planned date of the first injection. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to the planned date of the first injection. history of a serious reaction to prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. any history of anaphylaxis to any prior vaccine. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 70. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination. chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. an immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. active cancer (malignancy) therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the eos. known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first trial vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature > 38.0°c, on the planned day of vaccine administration). any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization, and study site personnel involved in the conduct or planning of the study).