Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.

After the analyses for this study were completed, questions arose regarding the integrity of
study data from a single study site in Romania, which enrolled 102 subjects in the trial.
Because evaluation of data from this site did not reveal irregularities when compared with
overall study data and because GSK has no current plans to use the data from the study in
support of any regulatory filings, they were not excluded from the analyses reflected in this
results summary.

Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol.

- A man or woman aged 65 years or older at the time of the vaccination.

- Written informed consent obtained from the subject.

- Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

- Bedridden subjects

- Previous vaccination against influenza since February 2008.

- Previous vaccination in the last three years with an investigational adjuvanted
candidate seasonal or pandemic influenza vaccine.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- Any contra-indication to intramuscular administration of the influenza vaccines.

- History of hypersensitivity to a previous dose of influenza vaccine.

- History of allergy or reactions likely to be exacerbated by any component of the
vaccine including egg and chicken protein.

- Acute disease at the time of enrolment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. All vaccines can be administered to
persons with a minor illness such as diarrhoea, mild upper respiratory infection with
or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).