Last updated: 11/07/2018 00:22:38

Study comparing the immune response of Fluarix and Fluzone influenza vaccines

GSK study ID
104437
Clinicaltrials.gov ID
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 phase III, observer-blind, randomized study to evaluate the immunogenicity and safety of Fluarix™ (GlaxoSmithKline Biologicals) compared with Fluzone® (Aventis Pasteur) administered intramuscularly in adults 18 years and older in the U.S.
Trial description: The purpose of this study is to compare two licensed influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and the safety/ any symptoms that may occur for up to six months after vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Influenza
  • Enrollment:
    1847
    Primary completion date:
    2006-22-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Campbell JD et al. (2011) Immunologic non-inferiority of a newly licensed inactivated trivalent influenza vaccine versus an established vaccine: a randomized study in US adults. Hum Vaccin. 7(1):81-88.
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • All adults 18 years and older.
    • Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.
    • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
    • Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15236
    Status
    Study Complete
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Study Complete
    Location
    GSK Investigational Site
    Warwick, Rhode Island, United States, 02886
    Status
    Study Complete
    Location
    GSK Investigational Site
    Carnegie, Pennsylvania, United States, 15106
    Status
    Study Complete
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    Study documents

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

    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
    2006-22-05
    Actual study completion date
    2006-07-06

    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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