Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in adults aged 18 years and older

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 or subjects with well-controlled chronic disease, 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.

Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

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

• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab etc.) within 6 months before study start, or planned administration 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 enrollment or during the study period.
• Clinically or virologically confirmed influenza infection within the 6 months preceding the study vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required):

Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.

• Acute disease and/or fever at the time of enrollment.

Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

• Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness. “Uncontrolled” is defined as:

Hospitalization or an event fulfilling the definition of a SAE within one month prior to study enrollment.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Subjects who participated in the registration trial [116664 (FLU Q-TIV-014)] for Fluviral™ 2012/2013 conducted in the 2012-2013 season.
• Presence of blood dyscrasias, including hemoglobinopathies and myelo- or lymphoproliferative disorder.
• A history of any demyelinating disease including Multiple Sclerosis and Guillain-Barré syndrome.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
• 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 or lactating female.
• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study or would make the intramuscular injection unsafe.