Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: PandemrixTM; FluarixTM/ Influsplit SSW® 2010/2011
Intervention description: One dose intramuscular injection; One dose intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H1N1; Pandemrix; Fluarix; Influenza

Summary:

      The aim of this study is to evaluate the immune response and the safety of one injection of
      FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single
      Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with
      any H1N1 pandemic vaccine will be enrolled as control.

      This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The
      impacted section is entry criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol. Specific attention should be given to the compliance potential of
             subjects with suspected or known drug and alcohol abuse.

          -  Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to
             be enrolled in the Groups A or B OR subjects who have not been previously vaccinated
             with a vaccine against the pandemic H1N1 strain at all, to be enrolled in group C.

          -  A male or female 18 years and above at the time of enrolment.

          -  Written informed consent obtained from the subject.

          -  Healthy subjects or free of acute aggravation of the health status 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.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the dose of study vaccine, or planned use during the study
             period.

          -  Administration of any influenza vaccine within 6 month prior to vaccination in this
             study.

          -  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 ≥ 37.5ºC, or acute symptoms greater than "mild"
             severity on the scheduled date of first vaccination.

          -  Diagnosed with cancer, or treatment for cancer, within the past 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..

          -  Any administration of a long-acting immune-modifying drug (within 3 months before
             study start, or a 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. 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 aspirin, and without a clinically-apparent
             bleeding tendency, are eligible.

          -  An acute evolving neurological disorder or history of Guillain-Barré syndrome.

          -  Clinically or virologically confirmed influenza infection within 6 months preceding
             the study start.

          -  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 from study inclusion up to 2 months after completion of the vaccination
             series.

          -  Any conditions which, in the opinion of the investigator, prevents the subjects from
             participating in the study.