Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

• Humoral immune response in terms of HI antibodies against each of the 3 vaccine influenza strains in subjects 18 years of age and above. [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
• Humoral immune response in terms of HI antibodies against each of the 3 vaccine influenza strains in subjects aged 18 years of age and above. [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

• Occurrence of solicited local and general adverse events (AEs). [ Time Frame: During a 4-day (Day 0 to 3) follow-up period after each vaccination ] [ Designated as safety issue: No ]
• Occurrence of unsolicited AEs. [ Time Frame: Within 21 days after vaccination (Day 0 - Day 20) ] [ Designated as safety issue: No ]
• Occurrence of serious adverse events (SAEs). [ Time Frame: From the beginning (Day 0) up to the study end (Day 21) ] [ Designated as safety issue: No ]

This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.

Inclusion Criteria:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female 18 years of age and older at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• 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 during the entire treatment period and for 2 months after completion of the vaccination.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period.
• Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period.
• Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
• Acute disease and/or fever at the time of enrolment.
• Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness.
• Any confirmed or suspected immunosuppressive or immunodeficient condition.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Insulin-dependent diabetes mellitus.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• History of chronic alcohol abuse and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g. low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of Fluviral® and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
• A history of severe adverse reaction to a previous influenza vaccination.
• Pregnant and/or lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.