Last updated: 11/03/2018 09:38:57

Study to evaluate the safety and immunogenicity of Fluarix™ 2006/2007 in adults aged 18 years or above

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GSK study ID
107507
See study documents
Clinicaltrials.gov ID
NCT00345904
EudraCT ID
2006-001918-33
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in people aged 18 years or above
Trial description: Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years.
This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Fluarix
    • Enrollment:
    120
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    July 2006 to August 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • A male or female aged 18 years or above at the time of the vaccination;
    • Healthy subjects or with well-controlled chronic diseases;
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female aged 18 years or above at the time of the vaccination;
    • Healthy subjects or with well-controlled chronic diseases;
    • If the subject is female, she must be of non-childbearing potential
    Exclusion criteria:
    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
    • Administration of an influenza vaccine within 6 months preceding the study start.
    • Administration of an influenza vaccine other than the study vaccine during the entire study
    • Clinically or virologically confirmed influenza infection within 6 months preceding the study start
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Acute disease at the time of enrolment.
    • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    • Not stabilized or clinically serious chronic underlying disease
    • Lactating female.
    • History of chronic alcohol consumption and/or drug abuse.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
    • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01099
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01277
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01097
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Freital, Sachsen, Germany, 01705
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-28-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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