A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above

Exclusion Criteria

• •1. Where applicable, FDA toxicity grades will be exclusionary.
• •2. Current or chronic conditions related with EXC criteria 1.
• •3. Immunosuppressive or immunodeficient conditions by history/exam; stable HIV-positive individuals on therapy can participate.
• •4. History of Guillain-Barré Syndrome within 6 weeks of receiving any vaccine.
• •5. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
• •6. Hypersensitivity to latex.
• •7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
• •8. History of hypersensitivity or allergic reaction to any previous influenza vaccine.
• •9. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
• •10. History of or current suspicion of myocarditis or pericarditis or medical condition increasing such risks.
• •11. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
• •12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
• •13. History of confirmed influenza infection by local health authority-approved testing methods within 180 days prior to study intervention administration.
• •14. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 28 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
• •15. Administration of an influenza vaccine within 180 days before the study intervention administration or planned administration prior to Visit 4 (Day 29) during the study.
• •16. Administration of any non-live attenuated non-study vaccine in the period starting 14 days before the study intervention administration or planned administration within 14 days after study intervention administration.
• •17. Administration of any live attenuated and/or mRNA non-study non-influenza vaccine in the period starting 28 days before the study intervention administration, or planned administration within 28 days after study intervention administration
• •18. Chronic administration of immune-modifying drugs.
• •19. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
• •20. Administration of antitumoral medication during the period starting 90 days before the study intervention or planned administration during the study period.
• •21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
• •22. Any study personnel or their immediate dependents, family, or household members.
• •23. History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• •24. Participant is pregnant.
• •25. Participant is breastfeeding or will (re)start breastfeeding during the study.