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

1. received covid-19 vaccines other than a covid-19 prototype or bivalent licensed mrna vaccine in the past, inclusive of clinical trial covid-19 vaccines. 2. participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination. 3. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination. 4. any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. 7. chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical or intranasal glucocorticoids is permitted. topical tacrolimus and ocular cyclosporin are permitted. use of inhaled glucocorticoids is prohibited. 8. received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 9. active cancer (malignancy) on 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). 10. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. 11. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 12. any other 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 study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 13. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization (cro), and study site personnel involved in the conduct or planning of the study). 14. participants with a history of myocarditis or pericarditis.

1. received covid-19 vaccines other than a covid-19 prototype or bivalent licensed mrna vaccine in the past, inclusive of clinical trial covid-19 vaccines. 2. participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination. 3. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination. 4. any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. 7. chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical or intranasal glucocorticoids is permitted. topical tacrolimus and ocular cyclosporin are permitted. use of inhaled glucocorticoids is prohibited. 8. received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 9. active cancer (malignancy) on 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). 10. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. 11. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 12. any other 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 study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 13. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization (cro), and study site personnel involved in the conduct or planning of the study). 14. participants with a history of myocarditis or pericarditis.

June 30, 2023, noon usa

received covid-19 vaccines other than a covid-19 prototype or bivalent licensed mrna vaccine in the past, inclusive of clinical trial covid-19 vaccines. participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination. any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. 7. chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical or intranasal glucocorticoids is permitted. topical tacrolimus and ocular cyclosporin are permitted. use of inhaled glucocorticoids is prohibited. 8. received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 9. active cancer (malignancy) on 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). 10. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. 11. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 12. any other 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 study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 13. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization (cro), and study site personnel involved in the conduct or planning of the study). 14. participants with a history of myocarditis or pericarditis.

received covid-19 vaccines other than a covid-19 prototype or bivalent licensed mrna vaccine in the past, inclusive of clinical trial covid-19 vaccines. participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination. received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination. any known allergies to products contained in the investigational product. 5. any history of anaphylaxis to any prior vaccine. 6. autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy. 7. chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination. note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical or intranasal glucocorticoids is permitted. topical tacrolimus and ocular cyclosporin are permitted. use of inhaled glucocorticoids is prohibited. 8. received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 9. active cancer (malignancy) on 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). 10. participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study. 11. suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 12. any other 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 study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 13. study team member or immediate family member of any study team member (inclusive of sponsor, contract research organization (cro), and study site personnel involved in the conduct or planning of the study). 14. participants with a history of myocarditis or pericarditis.