Last updated: 02/13/2019 07:42:04

Study to Evaluate an Influenza Vaccine Candidate

GSK study ID
110794
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: Immunogenicity, safety and reactogenicity of GSK Biologicals' influenza vaccine GSK1247446A with various formulations in subjects aged 18-64 years
Trial description: In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 18-64 years.
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, 21 and 180

Secondary outcomes:

Number of seroconverted subjects against 3 strains of influenza disease.

Timeframe: At Days 21 and 180

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

Timeframe: At Days 21 and 180

Number of seroprotected subjects against 3 strains of influenza disease.

Timeframe: At Days 0, 21 and 180

Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease.

Timeframe: At Days 0 and 21

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

Timeframe: At Days 0, 21 and 180

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

Timeframe: At Days 0, 21 and 180

Number of subjects with any and grade 3 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 medically significant conditions (MSCs).

Timeframe: From Day 0 to Day 180

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

Timeframe: During the 21-day (Days 0-20) post vaccination period

Number of subjects with serious adverse events (SAEs).

Timeframe: From Day 0 to Day 180

Interventions:
  • Biological/vaccine: Influenza Vaccine GSK1247446A – 4 different formulations
  • Biological/vaccine: Fluarix™
  • Enrollment:
    1006
    Primary completion date:
    2008-08-05
    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 2007 to May 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 years
    Accepts healthy volunteers
    Yes
    • Only subjects who the investigator believes that they can and will comply with the requirements of the protocol .
    • A male or female between, and including, 18 - 64 years of age at the time of vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01307
    Status
    Study Complete
    Location
    GSK Investigational Site
    Freiberg, Sachsen, Germany, 09599
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tuebingen, Baden-Wuerttemberg, Germany, 72074
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lille, France, 59019
    Status
    Study Complete
    Location
    GSK Investigational Site
    Caen cedex 4, France, 14052
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lagord, France, 17140
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-08-05
    Actual study completion date
    2008-08-05

    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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