Phase 3 Lot Consistency Study of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine

Inclusion Criteria:

• To be included in this study, each individual must satisfy all of the followingcriteria:

1. Willing and able to give informed consent prior to study enrollment.

2. Medically stable adult male or female ≥ 60 years of age at Screening.

3. Participants may have 1 or more chronic medical diagnoses, but should beclinically stable as assessed by:

4. Absence of changes in medical therapy in the past 2 months due totreatment failure or toxicity;

5. Absence of medical events qualifying as SAEs within 3 months; and

6. Absence of known, current, and life-limiting diagnoses which rendersurvival to completion of the protocol unlikely in the opinion of theInvestigator.

7. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, atScreening.

8. Participant must be able to receive an injection in the deltoid of at least onearm.

9. Able to attend study visits, comply with study requirements, and providereliable and complete reports of AEs.

10. Women of childbearing potential (defined as any female participant who is NOTsurgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateraloophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutivemonths]) must agree to be heterosexually inactive from at least 28 days priorto enrollment and through the end of the study OR agree to consistently use amedically acceptable method of contraception listed below from at least 28 daysprior to enrollment and through the end of the study.

11. Condoms (male or female) with spermicide (if acceptable in country)

12. Diaphragm with spermicide

13. Cervical cap with spermicide

14. Intrauterine device

15. Oral or patch contraceptives

16. Norplant®, Depo-Provera®, or other in-country regulatory approvedcontraceptive method that is designed to protect against pregnancy

17. Abstinence as a form of contraception, is acceptable if in line with theparticipant's lifestyle

18. Participants must agree to not participate in any other severe acuterespiratory syndrome coronavirus 2 (SARS-CoV-2) or influenza prevention ortreatment studies for the duration of the study. Note: For participants whobecome hospitalized with COVID-19 or influenza, participation ininvestigational treatment studies is permitted.

Exclusion Criteria:

• If an individual meets any of the following criteria, he or she is ineligible forthis study:

1. Any ongoing, symptomatic acute illness requiring medical or surgical care orchronic illness that required substantive changes in medication in the past 2months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the Investigator). This includes any current workup ofundiagnosed illness that could lead to a new condition.

2. Serious chronic diseases inclusive of:

3. Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOTexclusionary);

4. Congestive heart failure requiring hospitalization within 3 months priorto Screening (NOTE: stable congestive heart failure is NOT exclusionary);

5. Chronic obstructive pulmonary disease (COPD) requiring hospitalizationwithin 3 months prior to Screening (NOTE: stable COPD is NOTexclusionary);

6. Within 3 months prior to Screening, evidence of unstable coronary arterydisease as manifested by cardiac interventions (eg, cardiac stentplacement, coronary artery bypass graft surgery), new cardiac medicationsfor control of symptoms, or unstable angina (NOTE: stable coronary heartdisease is NOT exclusionary);

7. Hospitalization for diabetic ketoacidosis within 6 months prior toScreening

8. Chronic kidney disease/renal requiring institution of substantive newtherapy within 3 months prior to Screening

9. Chronic clinically significant gastrointestinal and hepatic diseasesrequiring hospitalization or institution of substantive new therapy within 3 months prior to Screening. (f or example, gastroesophageal refluxdisease is NOT exclusionary)

10. Chronic neurological diseases or neurological compromise preventing accessto the study clinic, compliance with protocol, or accurate reporting ofsafety.

11. Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.

12. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibodycocktails within 90 days prior to planned date of vaccination.

13. History of a serious reaction to a prior influenza vaccination or known allergyto constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigationalproduct.

14. Any history of anaphylaxis to any prior vaccine.

15. History of Guillain-Barré Syndrome within 6 weeks following a previousinfluenza vaccine.

16. Receipt of any vaccine in the 4 weeks preceding the study vaccination and anyinfluenza vaccine within 2 months preceding the study vaccination. Note:Routine vaccinations will not be allowed until after study Day 28 and COVID-19and influenza vaccination will not be allowed until after Day 28.

17. Any known or suspected autoimmune or immunosuppressive illness, congenital oracquired, based on medical history and/or physical examination (NOTE:well-controlled hypothyroidism and mild psoriasis are not exclusionary).

18. Chronic administration (defined as more than 14 continuous days) ofimmunosuppressants or other immune-modifying drugs within 6 months prior to theadministration of the study vaccines. An immunosuppressant dose ofglucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day orequivalent. The use of topical, inhaled, and nasal glucocorticoids ispermitted.

19. Administration of immunoglobulins and/or any blood products within the 3 monthspreceding the administration of the study vaccine or during the study.

20. Active cancer (malignancy) therapy within 1 year prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma orlentigo maligna and uterine cervical carcinoma in situ without evidence ofdisease, at the discretion of the Investigator).

21. Participants who are breastfeeding, pregnant, or who plan to become pregnantprior to the EoS.

22. Suspected or known history of alcohol abuse or drug addiction within 2 yearsprior to study vaccination, which in the opinion of the Investigator, mightinterfere with protocol compliance.

23. Acute disease at the time of enrollment (defined as the presence of a moderateor severe illness with or without fever, or an oral temperature ≥ 38.0°C, onthe planned day of vaccine administration).

24. Any condition that in the opinion of the Investigator would pose a health riskto the participant if enrolled or could interfere with evaluation of thevaccine or interpretation of study results (including neurologic or psychiatricconditions deemed likely to impair the quality of safety reporting).

25. Study team member or immediate family member of any study team member (inclusive of Sponsor, contract research organization, and study site personnelinvolved in the conduct or planning of the study).