Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluarix/Influsplit Tetra® (2013-2014 season)
Intervention description: 1 dose administered intramuscularly in the deltoid region of non-dominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Influenza; Adults; Safety; Elderly

Summary:

      The purpose of this study is to assess, in adults 18 years of age and above, the
      immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra
      containing the four influenza strains (two A strains and two B strains) for the 2013/2014
      season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  A male or female aged 18 years or above at the time of vaccination.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects or subjects with well-controlled chronic diseases as established by
             medical history and clinical examination before entering 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:

               -  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 vaccination.

        Exclusion Criteria:

          -  Participation in previous year's Fluarix registration study (116663).

          -  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.

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs within the six months prior to vaccination. Inhaled
             and topical steroids are allowed.

          -  Any administration of a long-acting immune-modifying drug within 6 months before study
             start, or planned administration during the study period.

          -  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 period.

          -  Administration of an influenza vaccine within the twelve months preceding the study
             vaccination.

          -  Receipt of a vaccine other than the study vaccine within 30 days before study
             vaccination and/or plan to receive any vaccine other than the study vaccine during the
             entire 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 enrollment.

               -  Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic
                  setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording
                  temperature in this study will be axillary.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease
             under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or
             clinically serious.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of Guillain-Barré syndrome.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine including latex.

          -  Anaphylaxis following the administration of vaccine(s).

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study or would make intramuscular injection unsafe.