Last updated: 11/04/2018 01:15:39

Reacto & immunogenicity of TF formulation of Influsplit SSW® 2002/03 v/s std formulation of Influsplit SSW® 2002/03

GSK study ID
218352/053
See study documents
Clinicaltrials.gov ID
NCT00731029
EudraCT ID
Not applicable
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: Comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years
Trial description: This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.

Timeframe: On Day 21 (± 2) after vaccination

Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms

Timeframe: Within 4 days after vaccination

Secondary outcomes:

Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms

Timeframe: Within 30 days after vaccination

Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)

Timeframe: During the entire study period.

Investigation of antibody persistence assessed by the criteria of the CHMP.

Timeframe: 11, 19, 27 weeks after vaccination

Interventions:
  • Biological/vaccine: Thiomersal free trivalent influenza split vaccine 2002/2003
  • Biological/vaccine: GlaxoSmithKline Biologicals’ Influsplit SSW®/Fluarix™ 2002/2003
    • Enrollment:
    239
    Primary completion date:
    2003-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza
    Product
    Influenza Vaccine (Split Virion, Inactivated)
    Collaborators
    Not applicable
    Study date(s)
    September 2002 to April 2003
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
    • The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
    • Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period
    • Acute disease at the beginning of the study
    Inclusion and exclusion criteria
    Inclusion criteria:

      Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.

      • The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
      • Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.
    Exclusion criteria:

      Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period

      • Acute disease at the beginning of the study
      • Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests
      • Pregnancy
      • Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
      • Known allergic reactions that might have been caused by one or more ingredients of the vaccine

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Clinical Trials Call Center
    Dresden, Germany
    Status
    Study Complete
    Contact us

    Study documents

    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
    2003-30-04
    Actual study completion date
    2003-30-04

    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

    Additional information
    Not applicable
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