Last updated: 11/03/2018 09:05:19

Incidence of influenza, downstream complications of influenza & hospitalizations in elderly vaccinated with Fluarix™

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GSK study ID
106622
See study documents
Clinicaltrials.gov ID
NCT00306982
EudraCT ID
Not applicable
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: An observational study to investigate the incidence of influenza, downstream complications of influenza and hospitalizations, in elderly subjects vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly.
Trial description: This study will investigate the incidence of influenza, disease and various possible downstream complications and hospitalizations or emergency room visits after routine annual vaccination of the elderly population with Fluarix™.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Fluarix
    • Enrollment:
    1524
    Primary completion date:
    2006-14-12
    Observational study model:
    Not applicable
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK2647158A, GSK576389A
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to December 2006
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    65+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria
    • All subjects must satisfy to the following criteria at study entry:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria All subjects must satisfy to the following criteria at study entry:
    • (1) A male or female age 65 years at the time of the first vaccination,
    • (2) Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., return for follow-up visits, disease reporting by phone, and completion of Questionnaires) should be enrolled in the study
    • (3) Written informed consent obtained from the subject
    • (4) Availability to follow up by phone during the study period
    • (5) Subjects with residence status allowing free mixing with general community. Exclusion Criteria The subject must not be included in the study for:
    • (1) history of hypersensitivity to a previous dose of influenza vaccine
    • (2) history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate,
    • (3) use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Clayton, Victoria, Australia, 3168
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Heidelberg Heights, Victoria, Australia, 3084
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hobart, Tasmania, Australia
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Parkville, Victoria, Australia, 3050
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Nedlands, Western Australia, Australia, 6009
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Garran, Australian Capital Territory, Australia, 2606
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 12 Results

    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
    2006-14-12
    Actual study completion date
    2006-14-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

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    Additional information
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