Last updated: 11/03/2018 00:59:16

Annual study for Fluarix registration

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GSK study ID
104745
See study documents
Clinicaltrials.gov ID
NCT00306943
EudraCT ID
2005-001555-38
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: Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People age 18 or beyond
Trial description: A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Influsplit SSW®
    • Enrollment:
    120
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to August 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
    • All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
    • 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.
    • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.

      • All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
      • Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language.
    Exclusion criteria:

      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.

      • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
      • Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
      • Pregnancy (exclusion by safe contraception; pregnancy test at day 0.
      • Known allergic reactions, probably caused by one or more vaccine ingredients.
      • Drug and/or Alcohol abusers

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01277
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01187
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01069
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01099
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01219
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-08-08

    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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