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

if an individual meets any of the following criteria, he or she is ineligible for this study: 1. history of laboratory-confirmed (by polymerase chain reaction (pcr) or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note: symptomatic covid-19 or asymptomatic sars-cov-2 infection \> 8 weeks prior to enrollment is not exclusionary) 2. any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. 3. serious chronic diseases inclusive of: 1. uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); 2. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); 3. chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); 4. in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting \[cabg\]) surgery, new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); 5. asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). 6. type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); 7. chronic kidney disease/renal insufficiency; 8. chronic gastrointestinal and hepatic diseases; or 9. chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). 4. participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. 5. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. 6. 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. 7. any history of anaphylaxis to any prior vaccine. 8. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 9. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. 10. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 11. 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is permitted. 12. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 13. active cancer (malignancy) therapy within 3 years prior to 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). 14. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (eos). 15. known disturbance of coagulation. 16. suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance. 17. 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). 18. history of myocarditis or pericarditis. 19. 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). 20. 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.

if an individual meets any of the following criteria, he or she is ineligible for this study: 1. history of laboratory-confirmed (by polymerase chain reaction (pcr) or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note: symptomatic covid-19 or asymptomatic sars-cov-2 infection \> 8 weeks prior to enrollment is not exclusionary) 2. any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. 3. serious chronic diseases inclusive of: 1. uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); 2. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); 3. chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); 4. in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting \[cabg\]) surgery, new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); 5. asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). 6. type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); 7. chronic kidney disease/renal insufficiency; 8. chronic gastrointestinal and hepatic diseases; or 9. chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). 4. participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. 5. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. 6. 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. 7. any history of anaphylaxis to any prior vaccine. 8. history of guillain-barré syndrome within 6 weeks following a previous influenza vaccine. 9. receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. 10. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 11. 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is permitted. 12. administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 13. active cancer (malignancy) therapy within 3 years prior to 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). 14. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study (eos). 15. known disturbance of coagulation. 16. suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance. 17. 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). 18. history of myocarditis or pericarditis. 19. 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). 20. 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.

Sept. 2, 2022, 10 p.m. usa

if an individual meets any of the following criteria, he or she is ineligible for this study: history of laboratory-confirmed (by polymerase chain reaction (pcr) or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note: symptomatic covid-19 or asymptomatic sars-cov-2 infection > 8 weeks prior to enrollment is not exclusionary) any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. serious chronic diseases inclusive of: uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [cabg]) surgery, new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; or chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. 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 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is 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 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 end of study (eos). known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which 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). history of myocarditis or pericarditis. 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.

if an individual meets any of the following criteria, he or she is ineligible for this study: history of laboratory-confirmed (by polymerase chain reaction (pcr) or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note: symptomatic covid-19 or asymptomatic sars-cov-2 infection > 8 weeks prior to enrollment is not exclusionary) any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. serious chronic diseases inclusive of: uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting [cabg]) surgery, new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); asthma with a history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; or chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. 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 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is 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 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 end of study (eos). known disturbance of coagulation. suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which 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). history of myocarditis or pericarditis. 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.

Aug. 30, 2022, 9:30 p.m. usa

if an individual meets any of the following criteria, he or she is ineligible for this study: history of laboratory-confirmed (by pcr or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note:symptomatic covid-19 or asymptomatic sars-cov-2 infection > 8 weeks prior to enrollment is not exclusionary) any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. serious chronic diseases inclusive of: uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery [cabg]), new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); asthma with history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; or chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. history of a serious reaction to a 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 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is 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 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 study vaccination, which 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). history of myocarditis or pericarditis. 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.

if an individual meets any of the following criteria, he or she is ineligible for this study: history of laboratory-confirmed (by pcr or rapid antigen test) covid-19 or asymptomatic sars-cov-2 infection ≤ 8 weeks prior to enrollment. (note:symptomatic covid-19 or asymptomatic sars-cov-2 infection > 8 weeks prior to enrollment is not exclusionary) any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). this includes any current workup of undiagnosed illness that could lead to a new condition. serious chronic diseases inclusive of: uncontrolled hypertension (note: well controlled hypertension ≤ grade 2 in not exclusionary); congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled congestive heart failure is not exclusionary); chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the prior 2 years (note: mild well-controlled copd is not exclusionary); in the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery [cabg]), new cardiac medications for control of symptoms, or unstable angina (note: stable coronary heart disease is not exclusionary); asthma with history of exacerbation in the prior 2 years or worsening of asthma symptoms or requiring changes in asthma control medications in the past 2 months (note: well-controlled asthma is not exclusionary). type 1 or type 2 diabetes (adult onset) requiring insulin (note: non-insulin dependent type 2 diabetes is not exclusionary); chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; or chronic neurological diseases (such as multiple sclerosis, dementia, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms (note: history of migraine or chronic headaches or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary). participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. use of covid-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. history of a serious reaction to a 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 8 weeks preceding the study vaccination. note: routine vaccinations will not be allowed until after study day 21 and covid and influenza vaccination will not be allowed until after day 84. any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (note: mild psoriasis is not exclusionary). 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 is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids is 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 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 study vaccination, which 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). history of myocarditis or pericarditis. 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.