Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Trivalent influenza vaccine GSK 138842A; Fluarix
Intervention description: IM injection on Day 0; IM injection on Day 0
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cell culture; Safety; Influenza; Humans; Adults; Immunogenicity; Influenza vaccine; Vaccine

Summary:

      The purpose of the study is to compare the safety of & immune response to a single dose of
      GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed,
      egg-based trivalent influenza vaccine [Fluarix] in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  A male or non-pregnant, non-lactating female between 18 and 49 years of age at the
             time of vaccination

          -  Access to a telephone for scheduled follow-up telephone contacts

          -  Ability to provide written informed consent

          -  Healthy subjects as established by medical history and physical examination before
             entering into the study

          -  If the subject is female, she must be of non-childbearing potential, or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination and continue such precautions for 2 months after receipt of the study
             vaccine. All women will have a pregnancy test on the day of vaccination.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the dose of study vaccine, or planned use
             during the study period

          -  Receipt of systemic glucocorticoids within 30 days of study enrollment

          -  Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other
             than glucocorticoids) or irradiation within 6 months prior to study enrollment or
             planned administration during the study period

          -  Administration of immunoglobulins and/or blood products within 3 months prior to study
             enrollment or planned administration during the study period

          -  Previous vaccination against influenza (2007-2008 influenza season)

          -  History of anaphylactic or other allergic reaction to influenza vaccine, any other
             vaccine, or any vaccine component or excipient

          -  History of Guillain-Barre Syndrome (GBS)

          -  Acute disease, febrile illness, or upper respiratory infection at screening.

          -  History of splenectomy

          -  Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or
             immunosuppressive condition (including human immunodeficiency virus [HIV]) based on
             medical history and physical examination

          -  Acquired or congenital coagulation disorders or known thrombocytopenia

          -  Current treatment with warfarin or heparin derivatives

          -  Known use of an analgesic or antipyretic medication within 12 hours prior to treatment
             for the purposes of prophylaxis of adverse events

          -  Any medical condition for which the US Advisory Committee on Immunization Practices
             recommends vaccination against influenza