A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults

Inclusion Criteria:

1. Males and females ≥60 years of age who are ambulatory and live in the community, or
in assisted-living or long-term care residential facilities that provide minimal
assistance, such that the subject is primarily responsible for self-care and
activities of daily living. Subjects may have one or more chronic medical diagnoses,
but should be clinically stable as assessed by:

- Absence of changes in medical therapy within one month due to treatment failure
or toxicity,

- Absence of medical events qualifying as SAEs within one month of the planned
vaccination on Day 0, and

- Absence of known, current, and life-limiting diagnoses which, in the opinion of
the investigator, render survival to completion of the protocol unlikely.

2. Willing and able (on both a physical and cognitive basis) to give informed consent
prior to study enrollment.

3. Able to comply with study requirements; including access to transportation for study
visits.

4. Access to inbound and outbound telephone communication with caregivers and study
staff.

Exclusion Criteria:

1. Participation in research involving investigational product (drug / biologic /
device) within 45 days before the planned date of the Day 0 vaccination.

2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome
(GBS) within 6 weeks of any prior influenza immunization.

3. Receipt of any vaccine other than an IIV in the 4 weeks preceding the study
vaccination or a pneumococcal vaccine in the 2 weeks preceding the study vaccination;
or any RSV vaccine at any time.

4. Any known or suspected immunosuppressive condition, acquired or congenital, as
determined by history and/or physical examination.

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

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

7. 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).

8. Known uncontrolled disorder of coagulation. Potential subjects receiving aspirin,
clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin
under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic
disease or stroke in the setting of atrial fibrillation will NOT be excluded.

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

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 study results (including neurologic, cognitive, or psychiatric
conditions deemed likely to impair the quality of study compliance or safety
reporting).