Last updated: 11/03/2018 09:40:44

Study on the incidence of influenza and its complications, in subjects aged 50 years and over vaccinated with Fluarix™

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GSK study ID
107564
See study documents
Clinicaltrials.gov ID
NCT00377611
See results summary
EudraCT ID
2006-002897-23
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 study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
Trial description: A study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with Fluarix™
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with at least one influenza-like-infection (ILI) episode

Timeframe: From Month 0 to Month 6

Number of subjects with laboratory-confirmed influenza infection type A and/or type B

Timeframe: From Month 0 to Month 6

Number of subjects with hospitalization, emergency room visits, or unscheduled medical office visits due to ILI

Timeframe: From Month 0 to Month 6

Number of subjects with hospitalizations, emergency room visits or unscheduled medical office visits, due to laboratory confirmed influenza

Timeframe: From Month 0 to Month 6

Number of subjects with hospitalization or emergency room visit for any cause

Timeframe: From Month 0 to Month 6

Number of subjects with emergency room visits, or unscheduled medical office visits due to influenza-related complications

Timeframe: From Month 0 to Month 6

Number of subjects with influenza-related complications

Timeframe: From Month 0 to Month 6

Number of subjects with fatal outcomes due to laboratory confirmed influenza infection

Timeframe: From Month 0 to Month 6

Number of subjects with fatal outcomes

Timeframe: From Month 0 to Month 6

Number of subjects with laboratory-confirmed Respiratory Syncytial Virus infection (RSV)

Timeframe: From Month 0 to Month 6

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 6

Number of seroconverted subjects for each influenza strain

Timeframe: At Day 21

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease

Timeframe: At Day 21

Number of seroprotected subjects against the 3 influenza strains

Timeframe: At Day 0 (PRE)

Number of seroprotected subjects against the 3 influenza strains

Timeframe: At Day 21

Number of seropositive subjects for each influenza strain

Timeframe: At Day 0 (PRE)

Number of seropositive subjects for each influenza strain

Timeframe: At Day 21

Serum HI antibody titers for each influenza strain

Timeframe: At Day 0 (PRE)

Serum HI antibody titers for each influenza strain

Timeframe: At Day 21

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Fluarix™
    • Enrollment:
    3054
    Primary completion date:
    2007-20-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK576389A
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to June 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    Yes
    • A male or female age 50 years or older at the time of the first vaccination.
    • non-childbearing female
    • Use of non-registered products
    • Pregnancy
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female age 50 years or older at the time of the first vaccination.
    • non-childbearing female
    • Availability to follow up by phone
    • Subjects with residence status allowing free mixing with general community
    Exclusion criteria:
    • Use of non-registered products
    • Pregnancy
    • Hypersensitivity to a previous dose of influenza vaccine
    • Acute disease at the time of enrolment/vaccination.
    • History of allergy or reactions likely to be exacerbated by any component of the vaccine
    • Any contra-indication to intramuscular administration of Fluarix™
    • For subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Camillus, New York, United States, 13031
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22143
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13359
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23507
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    Status
    Study Complete
    Contact us
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    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-20-06
    Actual study completion date
    2007-20-06

    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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