Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults

Inclusion Criteria:

1. Individuals are male, female, or transgender adults 18 to 49 years of age or 65 to 85 years of age.

2. Healthy participants or participants with pre-existing stable medical conditions.Pre-existing stable medical condition means a subject who: has full capacity ofdaily activity and no major medication modification; has not undergone surgical orminimally invasive intervention or had any hospitalization/emergency room visit forthe specific medical condition within 3 months prior to Day 1.

3. Participant or legally authorized representatives must freely provide documentedinformed consent prior to study procedures being performed.

4. Individuals who have not received influenza vaccine within 6 months prior toenrollment.

5. Individuals must agree to comply with all study visits and procedures (includingblood tests, nasopharyngeal swabs, diary completion, receipt of telephone calls fromthe site, willingness to be available for Unscheduled Clinic Visits).

6. Individuals of childbearing potential must be willing to adhere to contraceptiverequirements.

Exclusion Criteria:

1. Individuals with acute medical illness or febrile illness, including bodytemperature >100.4°F (>38.0°C) within 3 days prior to Randomization. Theseindividuals may be offered the opportunity to enter the study after fever andillness has stabilized. Participants with suspected or confirmed influenza should beexcluded and referred for medical care. Rescreening will be permitted forindividuals who are presented with suspected influenza if another diagnosis isconfirmed.

2. Individuals with any medical, neurological, or psychiatric condition that, in theopinion of the investigator, could place the participant at an unacceptable risk ofinjury or render the participant unable to comply with all study procedures andachieve successful completion of the trial.

3. Individuals with a known history of severe hypersensitivity reactions, includinganaphylaxis, or other significant adverse reactions to any mRNA vaccine, influenzavaccine, or excipients.

4. Individuals who have a positive pregnancy test at the Screening visit or Day 1 orwho intend to become pregnant or breastfeed during the study.

5. Individuals with a history of myocarditis, pericarditis, myopericarditis orcardiomyopathy.

6. Individuals with a history of Guillain-Barré syndrome, encephalomyelitis, ortransverse myelitis.

7. Individuals with a known bleeding disorder that would, in the opinion of theinvestigator, contraindicate intramuscular (I.M.) injection.

8. Individuals with a history of congenital or acquired immunodeficiency.

9. Individuals who have received immunomodulatory, immunostimulatory, orimmunosuppressant drugs including interferon and cytotoxic drugs within 3 months ofScreening/Day 1 or who plan to receive them during the study.

10. Individuals requiring systemic corticosteroids exceeding 10 mg/day of prednisoneequivalent for ≥10 days within 30 days of Screening. The use of topical, ophthalmic,inhaled, and intranasal steroid preparations will be permitted.

11. Individuals who have received immunoglobulins and/or any blood or blood productswithin the 3 months before the first vaccine administration or plan to receive suchproducts at any time during the study.

12. Individuals with an immunosuppressive or immunodeficient state, asplenia, orrecurrent severe infections.

13. Individuals with a documented history of chronic infection including HIV, HBV, HCV,or who are currently known to have active tuberculosis.

14. Individuals with chronic illness that, in the opinion of the Investigator, are at astage where it might interfere with trial participation or interpretation of studyresults.

15. Individuals receiving treatment with another investigational drug, biological agent,or device within 28 days of screening, or 5 half-lives of the investigational drug,whichever is longer; or are currently enrolled in or plan to participate in anotherclinical trial with an investigational agent during the study period.

16. Individuals who received any influenza vaccine within 6 months prior to enrollment.Individuals who plan to receive an influenza vaccine during the study period*.

17. Individuals who have received any other licensed vaccines within 14 days prior toenrollment in this study or who are planning to receive any vaccine up to 14 daysafter the study vaccination.

18. Individuals who are investigator site staff members, employees of the Sponsor or theClinical Research Organization directly involved in the conduct of the study, orsite staff members otherwise supervised by the investigator or immediate familymembers of any of the previously mentioned individuals.

• Participants in the older adult group (Part 3) are allowed, following their Day 29 visit, to receive the authorized influenza vaccine as per country-specificrecommendations.