Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Investigational H7N1 vaccine GSK2789869A; Placebo
Intervention description: Two doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.; Two doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 363.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H7N1; AS03 adjuvant; Safety; Immunogenicity; Influenza; Adults; Elderly adults

Summary:

      The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of
      different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age
      and older. The study will evaluate safety related events and antibody immune responses to
      different formulations of study vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults who are 65 years of age and older at the time of first study
             vaccination.

          -  Written informed consent obtained from the subject.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  Stable health status, as established by medical history and physical exam, and defined
             by absence of a health event satisfying the definition of a serious adverse event, or
             a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug
             toxicity, within 1 month prior to enrollment.

          -  Access to a consistent means of telephone contact, which may be either in the home or
             at the workplace, land line or mobile, but NOT a pay phone or other multiple-user
             device.

        Exclusion Criteria:

          -  Presence or evidence of neurological or psychiatric diagnoses which, although stable,
             are deemed by the investigator to render the potential subject unable/unlikely to
             provide accurate safety reports.

          -  Presence or evidence of substance abuse.

          -  Diagnosed with cancer, or treatment for cancer within three years.

               -  Persons with a history of cancer who are disease-free without treatment for three
                  years or more are eligible.

               -  Persons with a history of histologically-confirmed basal cell carcinoma of the
                  skin successfully treated with local excision only are excepted and are eligible,
                  but other histologic types of skin cancer are exclusionary.

               -  Women who are disease-free three years or more after treatment for breast cancer
                  and receiving long-term prophylaxis are eligible.

          -  Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day
             present almost daily for at least one month), or narcolepsy; or history of narcolepsy
             in subject's parent, sibling or child.

          -  Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Receipt of systemic glucocorticoids within 30 days prior to the first dose of study
             vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs
             within 6 months of first study vaccine/placebo dose. Topical, intra-articularly
             injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are
             allowed.

          -  Any significant disorder of coagulation or treatment with warfarin derivatives or
             heparin. Persons receiving individual doses of low molecular weight heparin outside of
             24 hours prior to vaccination are eligible. Persons receiving prophylactic
             antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent
             bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or Guillain Barré Syndrome within 42 days of
             receipt of prior seasonal or pandemic influenza vaccine.

          -  Administration of an inactive vaccine within 14 days or of a live attenuated vaccine
             within 30 days before the first dose of study vaccine/placebo.

          -  Planned administration of any vaccine other than the study vaccine/placebo before
             blood sampling at the Day 42 visit.

          -  Previous administration of any H7 vaccine or physician-confirmed H7 disease.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine/placebo, or planned use
             during the study period.

          -  Receipt of any immunoglobulins and/or any blood products within 90 days before the
             first dose of study vaccine/placebo, or planned administration of any of these
             products during the study period.

          -  Any known or suspected allergy to any constituent of influenza vaccines or component
             used in the manufacturing process of the study vaccine including a history of
             anaphylactic-type reaction to consumption of eggs; or a history of severe adverse
             reaction to a previous influenza vaccine.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study.