Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A; GSK investigational vaccine GSK2340272A
Intervention description: One intramuscular injection of initial process-manufactured GSK2340272A vaccine; Two intramuscular injections of initial process-manufactured GSK2340272A vaccine; One intramuscular injection of new process-manufactured GSK2340272A vaccine; Two intramuscular injections of new process-manufactured GSK2340272A vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Bio's influenza vaccine GSK2340272A

Summary:

      The objective of this study is to evaluate the immunogenicity and safety of one or two doses
      of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two
      different processes, in adults aged 18 to 60 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must satisfy ALL the following criteria at study entry:

          -  A male or female aged 18 to 60 years of age 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.

          -  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 (drug or vaccine) 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.

          -  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.

          -  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 coumarin derivatives, other
             vitamin K antagonists 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 acetylsalicylic acid,
             and without a clinically-apparent bleeding tendency, are eligible.

          -  Any contraindication to intramuscular administration of the influenza vaccines.

          -  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.