Last updated: 11/03/2018 10:39:26

Evaluate safety & immunogenicity of GSK Bio's influenza vaccine GSK576389A after repeated vaccination in elderly adults

GSK study ID
109821
Clinicaltrials.gov ID
EudraCT ID
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: Observer blind study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals influenza vaccine GSK576389A administered to adults over 65 years previously vaccinated with the same vaccine, compared to Fluarix™
Trial description: Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after repeated vaccine administration. In this observer blind study, the subjects previously enrolled in study 104888 (NCT00377585) will receive a dose with the 2007-2008 season's formulations of Fluarix or GSK576389A. Only subjects who were previously enrolled in study 104888 (NCT00377585) are eligible for participation in this study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects reporting any and grade 3 solicited local adverse events (AEs)

Timeframe: During a 7-day follow-up period after vaccination

Duration of solicited local adverse events

Timeframe: During a 7-day follow-up period after vaccination

Number of subjects reporting any, grade 3 and related solicited general adverse events (AEs)

Timeframe: During a 7-day follow-up period after vaccination

Duration of solicited general adverse events

Timeframe: During a 7-day follow-up period after vaccination

Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs)

Timeframe: During a 21-day follow-up period after vaccination

Secondary outcomes:

Number of subjects with any and related serious adverse events (SAEs)

Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

Number of subjects reporting any and related medically significant conditions (MSCs)

Timeframe: During the vaccination phase of the study (Day 0 to Day 20) and during the long term follow-up phase of the study (Day 21 to Day 179)

Serum hemagglutination-inhibition (HI) antibody titers against each of the three vaccine strains

Timeframe: At Days 0 and 21

Number of subjects seroconverted for HI antibodies against each of the three vaccine strains

Timeframe: At Day 21

Seroconversion factors for HI antibodies against each of the three vaccine strains

Timeframe: At Day 21

Number of subjects seroprotected for HI antibodies against each of the three vaccine strains

Timeframe: At Days 0 and 21

Number of Cluster of Differentiation 4 (CD4) T-cells (per million CD4 T-cells) producing at least 2 different immune markers

Timeframe: At Day 0 and 21

Number of CD4 T-cells (per million CD4 T-cells) producing at least CD40L and another immune marker

Timeframe: At Day 0 and 21

Number of CD4 T-cells (per million CD4 T-cells) producing at least IFN-γ and another immune marker

Timeframe: At Day 0 and 21

Number of CD4 T-cells (per million CD4 T-cells) producing at least IL-2 and another immune marker

Timeframe: At Day 0 and 21

Number of CD4 T-cells (per million CD4 T-cells) producing at least TNF-α and another immune marker

Timeframe: At Day 0 and 21

Number of Cluster of Differentiation 8 (CD8) T-cells (per million CD8 T-cells) expressing at least 2 different immune markers

Timeframe: At Day 0 and 21

Number of CD8 T-cells (per million CD8 T-cells) producing at least CD40L and another immune marker

Timeframe: At Day 0 and 21

Number of CD8 T-cells (per million CD8 T-cells) producing at least IFN-γ and another immune marker

Timeframe: At Day 0 and 21

Number of CD8 T-cells (per million CD8 T-cells) producing at least IL-2 and another immune marker

Timeframe: At Day 0 and 21

Number of CD8 T-cells (per million CD8 T-cells) producing at least TNF-α and another immune marker

Timeframe: At Day 0 and 21

Interventions:
  • Biological/vaccine: Fluarix
  • Biological/vaccine: GSK Biologicals Influenza Vaccine GSK576389A
  • Enrollment:
    1252
    Primary completion date:
    2007-21-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK576389A, SB218352
    Collaborators
    Not applicable
    Study date(s)
    October 2007 to June 2008
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
    • Written informed consent obtained from the subject.
    • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
    • Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Messkirch, Baden-Wuerttemberg, Germany, 88605
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bergen, Norway, 5094
    Status
    Study Complete
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13507
    Status
    Study Complete
    Location
    GSK Investigational Site
    Somers Point, New Jersey, United States, 08244
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hamar, Norway, 2317
    Status
    Study Complete
    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16506
    Status
    Study Complete
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    Study documents

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

    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
    2007-21-12
    Actual study completion date
    2008-04-06

    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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