Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
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.
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.