Last updated: 11/03/2018 09:22:53

Study to Evaluate an Influenza Vaccine Candidate

GSK study ID
107022
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: A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Trial description: The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old 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 virus

Timeframe: At Days 0 and 21 post-vaccination

Secondary outcomes:

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

Timeframe: At Day 180 post-vaccination.

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

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

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

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

Number of subjects with unsolicited adverse events (AEs).

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

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

Timeframe: During the entire study period (Day 0 to Day 180)

Interventions:
  • Biological/vaccine: Candidate Influenza Vaccine GSK1247446A – 2 different formulations
  • Biological/vaccine: FluarixTM
  • Enrollment:
    1220
    Primary completion date:
    2006-18-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    GSK1247446A
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to July 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    60+ years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • A male or female age 60 years or older at the time of the vaccination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Turku, Finland, 20520
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kotka, Finland, 48100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Haidari, Greece, 124 62
    Status
    Study Complete
    Location
    GSK Investigational Site
    Goudi / Athens, Greece, 115 27
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nikaia Piraeus, Greece, 184 54
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lahti, Finland, 15140
    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
    2006-18-07
    Actual study completion date
    2006-18-07

    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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