Last updated: 11/03/2018 00:12:20

A study in children with different formulations of GSK Biologicals' 11 valent pneumococcal conjugate vaccine

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GSK study ID
103488
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Clinicaltrials.gov ID
NCT00169481
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: A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age
Trial description: Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination

Timeframe: 1 Month after dose 3

Secondary outcomes:

1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.

Timeframe: 1 Month after dose 3

Interventions:
  • Biological/vaccine: Pneumococcal (vaccine)
    • Enrollment:
    689
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Streptococcal Infections
    Product
    GSK429353A
    Collaborators
    Not applicable
    Study date(s)
    October 2004 to May 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    8 - 16 weeks
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject. Exclusion criteria:
    • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
    • Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81675
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
    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
    Loehne, Nordrhein-Westfalen, Germany, 32584
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24937
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Flensburg, Schleswig-Holstein, Germany, 24944
    Status
    Study Complete
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    Showing 1 - 6 of 56 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2005-30-05

    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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