Last updated: 11/07/2018 03:48:24

Immunogenicity and safety of GSK Biologicals’ influenza vaccine versus a licensed comparator in children

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GSK study ID
111751
See study documents
Clinicaltrials.gov ID
NCT00764790
See results summary
EudraCT ID
2015-001258-13
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 and safety of GSK Biologicals’ thimerosal-free TIV flu vaccine versus a licensed comparator in children
Trial description: The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals’ seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Geometric Mean Titer (GMT) of serum anti-hemagglutinin (HA) antibodies against each of the influenza vaccine strains

Timeframe: Day 0 (PRE), Day 28 or Day 56 (POST)

Number of subjects who Seroconverted

Timeframe: Day 28 or Day 56

Secondary outcomes:

Number of Seroprotected Subjects

Timeframe: Day 0 (PRE), Day 28 or Day 56 (POST)

Seroconversion factor

Timeframe: Day 28 or Day 56

Number of subjects reporting solicited local symptoms

Timeframe: During a 4-day follow-up period after vaccination

Number of subjects reporting solicited general symptoms

Timeframe: During a 4-day follow-up period after vaccination

Number of subjects reporting unsolicited adverse events (AE)

Timeframe: During a 28-day follow-up period after vaccination

Number of subjects reporting serious adverse events (SAE) and new onset of chronic diseases (NOCD)

Timeframe: During the entire study (Day 0 until Month 6)

Number of subjects reporting rare serious events

Timeframe: During the entire study (Day 0 until Month 6)

Interventions:
  • Biological/vaccine: Fluarix
  • Biological/vaccine: Fluzone
    • Enrollment:
    3317
    Primary completion date:
    2009-05-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Pavia-Ruz N et al. (2013) A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 9(9):1978-1988.
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    October 2008 to June 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 35 months
    Accepts healthy volunteers
    Yes
    • A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
    • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
    • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
    • History of hypersensitivity to any vaccine.
    Inclusion and exclusion criteria
    Inclusion criteria:

      A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.

      • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
      • Written informed consent obtained from the subject’s parent/guardian.
    Exclusion criteria:

      Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.

      • History of hypersensitivity to any vaccine.
      • History of allergy or reactions likely to be exacerbated by any component of the vaccine.
      • Acute disease at the time of enrolment.
      • History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
      • Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
      • Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    St. Paul, Minnesota, United States, 55108
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cary, North Carolina, United States, 27518
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Paramount, California, United States, 90723
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Layton, Utah, United States, 84041
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Dothan, Alabama, United States, 36305
    Status
    Study Complete
    Contact us
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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
    2009-05-03
    Actual study completion date
    2009-01-06

    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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