Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK investigational vaccine GSK2340272A
Intervention description: One or two intramuscular injections in the deltoid region of the non-dominant or the dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A

Summary:

      The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A.
    

Eligibility criteria:

        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.

          -  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;
             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.