Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK2340272A; Influenza vaccine GSK2340274A
Intervention description: Two intramuscular injections at Day 0 and Day 21; Two intramuscular injections at Day 0 and Day 21
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A

Summary:

      The primary purpose of the study is to assess the equivalence of the immune response elicited
      by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and
      GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate
      the safety and reactogenicity of these two vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 to 60 years inclusive, 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.

          -  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

          -  Females of non-childbearing potential may be enrolled in the study.

          -  Female of childbearing potential may be enrolled in the study, if she:

          -  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.

          -  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 (99.5°F), 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.

          -  Clinically or virologically confirmed influenza infection within 6 months preceding
             the study start.

          -  Diagnosed with cancer, or treatment for cancer, within 3 years.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition including
             history of human immunodeficiency virus (HIV) infection.

          -  Clinically or virologically confirmed influenza infection within 6 months preceding
             the study start.

          -  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.

          -  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.