A phase III, observer-blind, multicountry, multicentre study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals' GSK2186877A influenza vaccine administered to adults aged 66 years and older compared to Fluarix* administered to adults aged 19-43 years and 66 years and older, who previously participated in the 111737 study.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 105

Inclusion Criteria

1. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, reporting by phone) should be enrolled in the study.
2. A male or female aged 19-43 years or *66 years at the time of the vaccination and who participated in the 111737 study and completed the 6-month follow-up.
3. Written informed consent obtained from the subject.
4. Free of an acute aggravation of the health status as established by clinical evaluation (medical history and physical examination) before entering into the study.
5. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study if the subject:
•has practiced adequate contraception for 30 days prior to vaccination, and
•has a negative pregnancy test on the day of vaccination, and
•has agreed to continue adequate contraception for 2 months after the vaccination.

Exclusion Criteria

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
2. Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
3. Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
4. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, *20 mg/day. Inhaled and topical steroids are allowed.)
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6. History of hypersensivity to a previous dose of influenza vaccine.
7. History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
8. Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation (medical history and physical examination) or pre-existing laboratory screening tests.
9. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature >=37.5°C on oral setting. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
10. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
11. Any medical conditions in which IM injections are contraindicated
12. Pregnant or lactating female.
13. Female planning to become pregnant or planning to discontinue contraceptive precautions.