Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK2340272A; GSK2340269A
Intervention description: Two intramuscular injections in the deltoid region of the non-dominant arm.; Two intramuscular injections in the deltoid region of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GSK Bio's influenza vaccine GSK2340272A; influenza infection

Summary:

      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational vaccine GSK2340272A in adults aged 18 to 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female aged 18 to 60 years 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 health event satisfying the definition of
             an SAE, 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 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 two 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 >= 37.5°C, or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Diagnosed with cancer, or treatment for cancer, within the past three years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Clinically or virologically confirmed influenza infection within six months preceding
             the study start.

          -  Chronic administration of immunosuppressants or other immune modifying drugs within
             six months of study enrolment or planned administration during the study period. For
             corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or
             equivalent for persons for > two weeks. Inhaled and topical steroids are allowed.

          -  Receipt of any immunoglobulins and/or any blood products within three 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 and without a clinically-apparent bleeding tendency, are
             eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome.

          -  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.