Last updated: 11/03/2018 10:03:41

Study to evaluate the immunogenicity and safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A low dose influenza vaccine candidate

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GSK study ID
108656
See study documents
Clinicaltrials.gov ID
NCT00374842
See results summary
EudraCT ID
2006-003769-15
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 the immunogenicity, safety and reactogenicity of adjuvanted influenza vaccine candidates compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years.
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Titers of serum haemagglutination-inhibition (HI) antibodies against each of the 3 influenza strains assessed.

Timeframe: At Day 0 and at Day 21.

Number of seroprotected subjects against each of the 3 influenza strains assessed.

Timeframe: At Day 0 and at Day 21.

Number of seroconverted subjects against each of the 3 influenza strains assessed

Timeframe: At Day 21.

Seroconversion factor against each of the 3 Influenza strains assessed.

Timeframe: At Day 21.

Secondary outcomes:

Number of subjects with any and grade 3 solicited local symptoms

Timeframe: Within the 7-day follow-up period (Days 0-6) after vaccination

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

Timeframe: Within the 7-day follow-up period (Days 0-6) after vaccination

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

Timeframe: Within the 30-day follow-up period (Days 0-29) after vaccination

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

Timeframe: From study start to study end, from Day 0 to Day 30

Interventions:
  • Biological/vaccine: Fluarix™
  • Biological/vaccine: GSK1247446A
    • Enrollment:
    300
    Primary completion date:
    2006-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK1247446A
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to November 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 59 years
    Accepts healthy volunteers
    Yes
    • A male or female aged 18-59 years at the time of the first vaccination.
    • Free of obvious health problems
    • Use of non-registered products
    • Administration of immune-modifying drugs.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female aged 18-59 years at the time of the first vaccination.
    • Free of obvious health problems
    Exclusion criteria:
    • Use of non-registered products
    • Administration of immune-modifying drugs.
    • Administration of vaccine 30 days before enrolment in study.
    • Immunosuppressive or immunodeficient condition.
    • Hypersensitivity to a previous dose of influenza vaccine
    • Previous vaccination against influenza in 2006
    • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
    • History of confirmed influenza infection within the last 12 Months.
    • Acute disease at the time of enrolment/vaccination.
    • History of allergy or reactions likely to be exacerbated by any component of the vaccine

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wilrijk, Belgium, 2610
    Status
    Study Complete
    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

    Results posted on ClinicalTrials.gov

    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

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