Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults
Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
 investigational vaccine GSK2340272A.
Inclusion Criteria:

 -  A male or female aged 18 years or above at the time of the first vaccination.

 -  Subjects who the investigator believes that they can and will comply with the
 requirements of the protocol.

 -  Written informed consent obtained from the subject.

 -  Satisfactory baseline medical assessment by history and physical examination. Stable
 health status is defined as the 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 one month prior to enrolment.

 -  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.

 -  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 series.

 Exclusion Criteria:

 -  Use of any investigational or non-registered product other than the study vaccine
 within 30 days preceding the first dose of the study vaccine or planned use during the
 study period. Potential subjects in the follow-up phase of a prior investigational
 study may be enrolled if the investigator's judgment is that it will have no effect on
 safety, reactogenicity, or immunogenicity endpoints in this study, and that it does
 not violate the protocol requirements of the prior trial.

 -  Presence of evidence of substance abuse or 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 of an axillary temperature >= 37.5ºC, or acute symptoms greater than "mild"
 severity on the scheduled date of first vaccination. NOTE: The subject may be
 vaccinated at a later date, provided symptoms have resolved, vaccination occurs within
 the window specified by the protocol, and all other eligibility criteria continue to
 be satisfied.

 -  Diagnosed with cancer, or treatment for cancer, within the past 3 years.

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

 -  Persons with a history of histological-confirmed basal cell carcinoma of the skin
 successfully treated with local excision only are excepted and may enrol within 3
 years of diagnosis, but other histological types of skin cancer require a 3 year
 untreated and disease-free window as above.

 -  Women who are disease-free 3 years or more after treatment for breast cancer and
 receiving long-term prophylactic hormonal therapy are excepted and may enrol.

 -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
 history of human immunodeficiency virus (HIV) infection.

 -  Chronic administration of immunosuppressants or other immune modifying drugs within 6
 months of study enrolment or planned administration during the study period.

 -  Receipt of any immunoglobulins and/or any blood products within 3 months of study
 enrolment or planned administration of any of these products during the study period.

 -  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 history of Guillain-Barré syndrome.

 -  Clinically or virologically confirmed influenza infection within 6 months preceding
 the study start.

 -  Administration of any vaccines within 30 days before vaccination.

 -  Any known or suspected allergy to any constituent of influenza vaccines; a history of
 anaphylactic-type reaction to any constituent of influenza vaccines; or a history of
 severe adverse reaction to a previous influenza vaccine.

 -  Pregnant or lactating female

 -  Female planning to become pregnant or planning to discontinue contraceptive
 precautions.

 -  Any conditions which, in the opinion of the investigator, prevents the subjects from
 participating in the study.