A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

• Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
  Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
• Number of Seroprotected Subjects [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
  A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
• Number of Seroconverted Subjects [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  A seroconverted subject is a subject with a pre-vaccination serum HI titer < 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
• Seroconversion Factor [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
• Seroprotection Power [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  Seroprotection power is defined as the number of subject who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40

• Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
• Evaluation of the humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

• Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
  Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
• Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ] [ Designated as safety issue: No ]
  Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.
• Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ] [ Designated as safety issue: No ]
  An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
• Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the entire study period (From Day 0 up to Day 21) ] [ Designated as safety issue: No ]
  An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

• Percentage, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms [ Time Frame: During 21 days following vaccination ] [ Designated as safety issue: No ]
• Percentage, intensity and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period (From Day 0 up to Day 21) ] [ Designated as safety issue: No ]

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.

• Experimental: Fluarix Adult Group
  Subjects aged 18 to 60 years received one dose of Fluarix™.
  Intervention: Biological: Fluarix™/Influsplit SSW®
• Experimental: Fluarix Elderly Group
  Subjects aged > 60 years received one dose of Fluarix™.
  Intervention: Biological: Fluarix™/Influsplit SSW®

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged 18 years or above at the time of the vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Administration of an influenza vaccine within 6 months preceding the study start.
• Administration of an influenza vaccine other than the study vaccine during the entire study
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Not stabilized or clinically serious chronic underlying disease.
• Lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.