Last updated: 11/07/2018 17:21:04

Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza vaccines) in young and older adults

Request patient level data
GSK study ID
IDB-200-001
See study documents
Clinicaltrials.gov ID
NCT00380211
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: A Randomized, Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine with reduced Preservative (FluLaval™ TR) and a Standard Influenza Vaccine (Fluarix®) in subjects between 18-60 and Over 60 Years of Age.
Trial description: The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Influenza vaccine (A/H3N2, A/H1N1, and B strains)
  • Biological/vaccine: Fluarix
    • Enrollment:
    660
    Primary completion date:
    2006-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    Influenza Vaccine (Split Virion, Inactivated, Fluviral)
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to November 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Male or female adults (≥18 yrs)
    • Stable health status
    • Febrile illness (>38.0°C oral temperature)
    • High blood pressure (≥140/90 mmHg)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female adults (≥18 yrs)
    • Stable health status
    • Provide informed consent
    • Access to direct phone service (NOT a pay phone or a common-use phone service)
    • Eligible females must have a negative pregnancy test
    Exclusion criteria:
    • Febrile illness (>38.0°C oral temperature)
    • High blood pressure (≥140/90 mmHg)
    • Significant acute or chronic
    • Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
    • Immunosuppressive condition (confirmed or suspected)
    • Renal impairment
    • Hepatic dysfunction
    • Complicated insulin-dependent diabetes mellitus
    • Unstable cardiopulmonary disease
    • Blood dyscrasias
    • Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
    • History of demyelinating disease
    • Active neurological disorder
    • Significant alcohol or drug abuse
    • Significant coagulation disorder (prophylactic antiplatelet medications allowed)
    • Influenza vaccine administrated within 6 months prior to study vaccination
    • Administration of any other vaccine from 30 days prior to the end of the study
    • Use of non-registered drug within 30 days prior to study vaccination
    • Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
    • History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
    • Pregnant or nursing female subjects
    • Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Binghamton, New York, United States, 13901
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Burke, Virginia, United States, 22015
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76135
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66219
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78705
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33173
    Status
    Recruiting
    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
    2006-30-11
    Actual study completion date
    2006-30-11

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website