Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Trivalent Split Virion Influenza Vaccine Fluviral™ (2013-2014 Season) in Adults Aged 18 Years and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluviral™
Intervention description: 1 dose administered intramuscularly in 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: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Trivalent; Safety; Adults; Elderly; Influenza

Summary:

      The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of
      Fluviral™ containing the influenza strains recommended for the 2013-2014 season in adults
      aged 18 years and older.
    

Eligibility criteria:

        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 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:

               -  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 dose.

        Exclusion Criteria:

          -  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):

               -  History of human immunodeficiency virus (HIV) infection,

               -  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.

               -  Acute disease is defined as the presence of a short term, moderate or severe
                  illness, with or without fever.

               -  Fever is defined as temperature ≥ 38.0°C/100.4°F for oral, axillary or tympanic
                  route. The preferred route for recording temperature in this study will be oral.

               -  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:

               -  Requiring institution of new medical or surgical treatment within one month prior
                  to study enrollment, or

               -  Requiring the re-institution of a previously discontinued medication or medical
                  treatment within one month prior to study enrollment, or

               -  Requiring a change in medication dosage in the one month prior to study
                  enrollment due to uncontrolled symptoms or drug toxicity (elective dosage
                  adjustments in stable subjects are acceptable), or

               -  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.