Last updated: 11/03/2018 09:51:12

Study to evaluate the immunogenicity and the safety of an adjuvanted influenza vaccine candidate

Request patient level data
GSK study ID
107975
See study documents
Clinicaltrials.gov ID
NCT00363077
See results summary
EudraCT ID
2006-002680-18
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 candidate compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly aged 60 years and older.
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.

Timeframe: At Days 0 and 21

Number of seroconverted subjects against 3 strains of influenza disease.

Timeframe: At Day 21

Number of seroprotected subjects against 3 strains of influenza disease.

Timeframe: At Day 0 and Day 21

Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.

Timeframe: At Day 21

Secondary outcomes:

Geometric mean of influenza-specific Cluster of Differentiation (CD) 4 T-cells.

Timeframe: At Days 0 and 21

Geometric mean of influenza-specific Cluster of Differentiation (CD) 8 T-cells.

Timeframe: At Days 0 and 21

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

Timeframe: During the 7-day (Days 0-6) post-vaccination period

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

Timeframe: During the 7-day (Days 0-6) post-vaccination period

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

Timeframe: During the 30-day (Days 0-29) post vaccination period

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

Timeframe: During the entire study period (from Day 0 to Day 29)

Interventions:
  • Biological/vaccine: GSK1247446A Group
  • Biological/vaccine: Fluarix™
    • Enrollment:
    150
    Primary completion date:
    2006-17-11
    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
    60+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
    • A male or female 60 years or older at the time of the first vaccination.
    • Use of non-registered products
    • Administration of immune-modifying drugs.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study.
    • A male or female 60 years or older 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
    • Acute 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
    Gent, Belgium, 9000
    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
    2006-17-11
    Actual study completion date
    2006-17-11

    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