Last updated: 07/17/2024 15:09:18

Immunogenicity, safety of GSKs Tdap vaccine Boostrix when coadministered with GSKs influenza vaccine Fluarix in adults

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GSK study ID
106323
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Clinicaltrials.gov ID
NCT00385255
See results summary
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 study to evaluate immunogenicity and safety of Boostrix when co-administered with Fluarix in subjects 19 years of age and older
Trial description: The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of seroprotected subjects against diphteria (D) and tetanus (T) toxoid antigens

Timeframe: At Month 1 post-Boostrix® vaccination

Number of subjects with anti-T antibody concentrations ≥ the assay cut-off value

Timeframe: At Month 1 post-Boostrix® vaccination

Antibody concentrations against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) antigens

Timeframe: At Month 1 post-Boostrix® vaccination

Number of subjects with serum haemagglutinin inhibition (HI) titers against 3 strains of influenza

Timeframe: At Month 1 post-Fluarix® vaccination

Number of seroconverted subjects against influenza antigens H1N1, H3N2, and B

Timeframe: At Month 1 post-Fluarix® vaccination

Secondary outcomes:

Number of seropositive subjects with anti-D antibody concentrations above the cut-off value

Timeframe: At Month 1 post-Boostrix® vaccination

Antibody concentrations for diphteria toxoid (D) and tetanus toxoid (T)

Timeframe: At Day 0 and Month 1 post-Boostrix® vaccination

Antibody concentrations for pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN)

Timeframe: At Day 0 and Month 1 post-Boostrix® vaccination

Number of subjects with booster response against diphteria toxoid (D) and tetanus toxoid (T) antigens

Timeframe: At Month 1 post-Boostrix® vaccination

Number of subjects with booster response against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) antigens

Timeframe: At Month 1 post-Boostrix® vaccination

Anti-H1N1, anti-H3N2 and anti-B antibody titers

Timeframe: At Month 1 post-Fluarix® vaccination

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 15-day (Day 0-14) period following each dose and across doses, up to 2 months

Number of subjects with any unsolicited adverse events (AEs)

Timeframe: During the 31-day period (Day 0-30) following each vaccination, up to 2 months

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the whole study period (from Day 0 to Month 2)

Interventions:
  • Biological/vaccine: Fluarix®
  • Biological/vaccine: Boostrix®
    • Enrollment:
    1726
    Primary completion date:
    2007-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Weston WM et al. (2009) Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults. Human Vaccines. 5(12): 858-866.
    Weston WM et al. (2012) Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials. Vaccine. 30(9):1721-1728.
    Medical condition
    acellular pertussis, Diphtheria, Tetanus
    Product
    SB776423
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to February 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    19+ years
    Accepts healthy volunteers
    Yes
    • Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
    • Administration of an influenza vaccine within six months prior to study entry
    • Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
    Exclusion criteria:
    • Administration of an influenza vaccine within six months prior to study entry
    • Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
    • Administration of a Tdap vaccine at any time prior to study entry.
    • Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
    • History of diphtheria and/or tetanus and/or pertussis disease.
    • History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Huntsville, Alabama, United States, 35802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Inverness, Florida, United States, 34452
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32935
    Status
    Study Complete
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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
    2007-28-02
    Actual study completion date
    2007-28-02

    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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