A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

1. Adults of ≥65 years of age on the day of vaccination.

2. Individuals who have voluntarily given written informed consent after the nature ofthe study has been explained according to local regulatory requirements, prior tostudy entry.

3. Individuals who have the ability to comply with study procedures includingfollow-up.

Exclusion Criteria:

In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:

1. Bedridden subjects (i.e. confined to bed by sickness or old age).

2. Subjects that are incapacitated and because of that in need of a Legally AuthorizedRepresentative.

3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan toreceive influenza vaccine while participating in the study.

4. Hypersensitivity, including allergy, to any component of vaccines whose use isforeseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previousinfluenza vaccination.

5. Known history of Guillain-Barré syndrome or another demyelinating disease such asencephalomyelitis and transverse myelitis.

6. Clinical conditions representing a contra-indication to intramuscular administrationof vaccines or blood draw.

7. Abnormal function of the immune system resulting from:

8. Clinical conditions;

9. Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day ofprednisone (or equivalent) for more than 14 consecutive days within 90 daysprior to informed consent; Topical, inhaled and intranasal corticosteroids arepermitted. Intermittent use (one dose in 30 days) of intra-articularcorticosteroids are also permitted;

10. Administration of antineoplastic and immunomodulating agents or radiotherapywithin 90 days prior to informed consent.

11. Receipt of immunoglobulins or any blood products within 180 days prior to informedconsent.

12. Receipt of any investigational or non-registered product (drug or vaccine) otherthan the study vaccine within 30 days preceding the study vaccination, or planneduse during the entire study period.

13. Acute (severe) febrile illness.

14. Any other clinical condition that, in the opinion of the investigator, mightinterfere with the results of the study or pose additional risk to the subject dueto participation in the study.

15. Study personnel or immediate family members (brother, sister, child, parent) or thespouse of study personnel.