Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)

Inclusion Criteria:

1. Healthy older adults, male or female,

2. Willing and able to give informed consent prior to trial enrollment, and

3. Able to attend trial visits, comply with trial requirements, and provide reliable and
complete reports of adverse events.

Exclusion Criteria:

1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.

- Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia)
that are not associated with evidence of end-organ damage are not exclusionary
provided that they are being appropriately managed and are clinically stable (ie,
unlikely to result in symptomatic illness within the time-course of this trial)
in the opinion of the investigator.

- Acute or chronic illnesses or conditions which may be reasonably predicted to
become symptomatic if treatment were withdrawn or interrupted are exclusionary,
even if stable.

- Acute or chronic illnesses reasonably expected to be associated with increased
risks in the event of influenza infection (eg, cardio-pulmonary diseases,
diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are
exclusionary, even if stable.

- Note that illnesses or conditions may be exclusionary, even if otherwise stable,
due to therapies used to treat them (see exclusion criteria 2, 5, 8, 9).

2. Participation in research involving investigational product (drug / biologic / device)
within 45 days before planned date of first injection.

3. History of a serious reaction to prior influenza vaccination, or known allergy to
constituents of influenza vaccines - including egg proteins - or polysorbate 80.

4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza
vaccine.

5. Receipt of any vaccine in the 4 weeks preceding the trial vaccination and any
influenza vaccine within 6 months preceding the trial vaccination.

6. Any known or suspected immunosuppressive illness, congenital or acquired, based on
medical history and/or physical examination.

7. 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
trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a
systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical,
inhaled, and nasal glucocorticoids will be permitted.

8. Administration of immunoglobulins and/or any blood products within the 3 months
preceding the administration of the trial vaccine or during the trial.

9. 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).

10. Any condition that in the opinion of the investigator would pose a health risk to the
subject if enrolled or could interfere with evaluation of the vaccine or
interpretation of trial results (including neurologic or psychiatric conditions deemed
likely to impair the quality of safety reporting).

11. Known disturbance of coagulation.

12. Suspicion or recent history (within one year of planned vaccination) of alcohol or
other substance abuse.