Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza vaccine GSK2321138A; FluarixTM; Influenza vaccine GSK2604409A
Intervention description: One intramuscular injection; One intramuscular injection; One intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4659.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza infection; GSK Biologicals influenza vaccine GSK2321138A

Summary:

      This study is designed to assess the safety and immunogenicity of a GSK Biologicals'
      investigational vaccine GSK2321138A in adults 18 years old and older. This study is also
      designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be
      double blind for all groups except for the GSK2604409A Group which will be open.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female 18 years of age or older at the time of the first vaccination

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects or those with chronic well-controlled disease as established by
             physical examination before entering into the study.

          -  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 urine 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 dose of the study vaccine or planned use during the study
             period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             three months prior to enrolment in this study or planned administration during the
             study period.

          -  Administration of an influenza vaccine during the 6 months preceding entry into the
             study.

          -  Planned administration / administration of a vaccine not foreseen by the study
             protocol within 30 days before vaccination and up to Day 21.

          -  Any contra-indication to intramuscular administration of the influenza vaccines.

          -  History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine,
             history of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  Any administration of a long-acting immune-modifying drug within 3 months before study
             start, or planned administration during the study period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Acute disease and/or fever at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests.

          -  History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated
             influenza virus vaccine.

          -  Administration of immunoglobulins and/or any blood products within the three months
             prior to the enrolment in this study, or planned during the study.

          -  History of chronic alcohol consumption and/or drug abuse.

          -  Any condition which, in the opinion of the investigator, prevents the subject from
             participating in the study

          -  Pregnant or lactating female.