Last updated: 06/13/2019 12:30:16

A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New versus Aged Bulk

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GSK study ID
111258
See study documents
Clinicaltrials.gov ID
NCT00586469
See results summary
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: Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age from 18 to 60 Years
Trial description: Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Geometric Mean Titers (GMTs) of anti-H3 and B strains

Timeframe: At Day 21

Secondary outcomes:

Geometric mean titers (GMTs) of the H1 strain and the GMT of the H3 and B strains

Timeframe: At Days 0 and 21

Number of participants who seroconverted.

Timeframe: At Day 21.

Number of seroprotected participants.

Timeframe: At Days 0 and 21

Seroconversion Factors defined as the fold increase in serum HI GMTs post-vaccination for influenza antigen H1N1

Timeframe: At Day 21 compared to Day 0

The fold increase in anti-HI GMTs for influenza antigens H3 and B

Timeframe: At Day 21 compared to Day 0

Number of participants reporting solicited local symptoms

Timeframe: During the 4-day follow up period following vaccination.

Number of participants reporting solicited general symptoms

Timeframe: During the 4-day period following each vaccination.

Number of participants reporting unsolicited adverse events (AE).

Timeframe: During the 21-day period following each vaccination.

Number of participants reporting serious adverse events (SAE)

Timeframe: Within 21 days after vaccination

Interventions:
  • Biological/vaccine: Fluviral
    • Enrollment:
    1000
    Primary completion date:
    2008-14-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Influenza Vaccines
    Product
    GSK1536489A
    Collaborators
    Not applicable
    Study date(s)
    December 2007 to January 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
    • Male and female adults, 18 to 60 years.
    • Acute disease at the time of enrollment.
    • Any confirmed or suspected immunosuppressive condition
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
    • Male and female adults, 18 to 60 years.
    • Written informed consent obtained from the subject.
    • If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
    Exclusion criteria:
    • Acute disease at the time of enrollment.
    • Any confirmed or suspected immunosuppressive condition
    • Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
    • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
    • A history of any demyelinating disease including Guillain-Barré syndrome.
    • Presence of an active neurological disorder.
    • Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
    • Receipt of an influenza vaccine within 6 months prior to study enrollment.
    • Administration of any vaccines within 30 days prior to study enrollment or during the study period.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
    • Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
    • A history of severe adverse reaction to a previous influenza vaccination.
    • Lactating/nursing female.
    • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coquitlam, British Columbia, Canada, V3K 3P4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gatineau, Québec, Canada, J8Y 6S8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Quebec, Québec, Canada, G1W 4R4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 1Z1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 4J6
    Status
    Study Complete
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    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
    2008-14-01
    Actual study completion date
    2008-14-01

    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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