RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly

Inclusion Criteria:

- Adult males and females, ≥ 60 years of age, without symptomatic cardiopulmonary
disease. Note that subjects who have any functional limitation or symptoms related to
cardiac and/or pulmonary disease (including asthma or other episodic symptoms), or
who receive ongoing therapy to control symptoms or functional limitation, are not
eligible. The following are examples of subjects who may bear cardio-pulmonary
diagnoses but who would remain eligible:

1. Subjects on stable (no change in ≥ 2 months) therapy for findings (e.g.,
hypertension or hyperlipidemia) that are not associated with current symptoms or
disability.

2. Subjects who receive intermittent prophylaxis for risks associated with
asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures
in a subject with asymptomatic mitral valve prolapse).

3. Other clinically insignificant findings, not deemed to be associated with
increased risk due to respiratory viral infections as determined by the
Investigator.

- Free of other illnesses which are believed to increase the risk of influenza or
influenza related complications including: diabetes mellitus, congenital or acquired
blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.

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

- Able to comply with study requirements.

Exclusion Criteria:

- Participation in research involving investigational product (drug / biologic /
device) within 45 days before planned date of first vaccination and/or planned
participation at any time during the study.

- History of a serious reaction to any prior vaccination or known allergy to
constituents of licensed TIV (e.g., egg proteins).

- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza
vaccine.

- Receipt of any influenza vaccine within the preceding 3 months.

- Receipt of any vaccine in the 4 weeks preceding the study vaccination and planned
receipt of a licensed vaccine any time prior to Day 56.

- Receipt of an RSV vaccine at any time.

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

- 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 ≥10 mg of prednisone per day or equivalent. The use of
topical, inhaled, and nasal glucocorticoids will be permitted provided these are not
administered for diagnoses inconsistent with the inclusion criteria. The use of
inhaled glucocorticoids, although typically not associated with system absorption,
will generally indicate the presence of a diagnosis inconsistent with inclusion
criteria 1 or 2.

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

- 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).

- Known disturbance of coagulation.

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

- 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 or psychiatric conditions
deemed likely to impair the quality of safety reporting).