Last updated: 07/18/2020 12:13:58

Study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6 - 13 years

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GSK study ID
106252
See study documents
Clinicaltrials.gov ID
NCT00372255
See results summary
EudraCT ID
2005-004517-14
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: An open, phase IV study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6 – 13 years
Trial description: The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease in children aged between 6 and 9 years

Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)

Seroconversion factor (SCF) for HI antibodies against 3 strains of influenza disease in children aged between 6 and 9 years

Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)

Number of seroconverted subjects against 3 strains of influenza disease in children aged between 6 and 9 years

Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)

Secondary outcomes:

Titers for serum HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years

Timeframe: 21 days post-vaccination (Day 21)

SCF for HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years

Timeframe: 21 days post-vaccination (Day 21)

Number of seroconverted subjects against 3 strains of influenza disease in children aged between 10 and 13 years

Timeframe: 21 days post-vaccination (Day 21)

Number of seroprotected subjects who were unprotected at pre-vaccination against 3 influenza strains in children aged between 10 and 13 years

Timeframe: 21 days post-vaccination (Day 21)

Number of seroprotected subjects against 3 strains of influenza disease in children aged between 10 and 13 years

Timeframe: 21 days post-vaccination (Day 21)

Number of subjects with solicited local symptoms

Timeframe: During the 4-day (Day 0–3) post-vaccination period following each dose and across doses

Number of subjects with solicited general symptoms

Timeframe: During the 4-day (Day 0–3) post-vaccination period following each dose and across doses

Number of subjects with unsolicited adverse events.

Timeframe: During 31 days after the study vaccine dose (Day 0-30)

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group

Interventions:
  • Biological/vaccine: Influsplit SSW® 2005/2006
    • Enrollment:
    240
    Primary completion date:
    2006-28-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Schmidt-Ott R et al. (2007) Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 26(1):32-40.
    Medical condition
    Influenza
    Product
    SB218352
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to March 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 13 years
    Accepts healthy volunteers
    Yes
    • Healthy children or children with an increased health risk due to an underlying chronic disease—such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases—aged between 6 and 13 years.
    • All subjects must not have received a prior influenza vaccination.
    • Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
    • Acute illness at the start of the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy children or children with an increased health risk due to an underlying chronic disease—such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases—aged between 6 and 13 years.
    • All subjects must not have received a prior influenza vaccination.
    • All subjects must not have had a prior influenza disease.
    Exclusion criteria:
    • Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
    • Acute illness at the start of the study.
    • Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
    • Known allergic reactions which might be caused by the ingredients of the vaccine.
    • Girls post-menarche: pregnancy or positive pregnancy-test
    • Multiple sclerosis or congenital or acquired immunodeficiencies.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10999
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10315
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13055
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bischofswerda, Sachsen, Germany, 01877
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bredstedt, Schleswig-Holstein, Germany, 25821
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Buetzow, Mecklenburg-Vorpommern, Germany, 18246
    Status
    Study Complete
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    Showing 1 - 6 of 18 Results

    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
    2006-28-03
    Actual study completion date
    2006-28-03

    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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