Last updated: 11/07/2018 02:19:42
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Study in adolescents/adults to evaluate the persistence up to 3.5 yrs of GSK Biologicals meningococcal vaccine 134612

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GSK study ID
108595 Mth18
See study documents
Clinicaltrials.gov ID
NCT00390143
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assess long term persistence of a primary dose of GSK Biologicals' meningococcal vaccine 134612 versus one dose of Mencevax™ ACWY in healthy adolescents/young adults (15 to 19 years at vaccination)
Trial description: This study will investigate the long-term protection offered by GSK Biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. Subjects were vaccinated at 15 to 19 years of age. This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled. This protocol posting deals with objectives & outcome measures of the extension phase 18, 30 and 42 months after vaccination. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00126945). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Meningococcal rSBA titres.

Timeframe: At the start of this persistence study and 12 and 24 months later.

Anti-meningococcal polysaccharide concentrations

Timeframe: At the start of this persistence study and 12 and 24 months later.

Occurrence of serious adverse events related to vaccination, adverse events related to lack of vaccine efficacy or study participation.

Timeframe: From the last study contact of the primary vaccination study to the end of this persistence study.

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Meningococcal vaccine 134612
  • Biological/vaccine: Mencevax™ ACWY
    • Enrollment:
    46
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Østergaard L et al. (2012) Persistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135 and Y tetanus toxoid-conjugate vaccine (MenACWY-TT). Int J Infect Dis. pii: S1201-9712(12)01269-6. doi: 10.1016/j.ijid.2012.10.001. [Epub ahead of print]
    Medical condition
    Infections, Meningococcal
    Product
    GSK134612A, SB208144
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to May 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 19 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
    • A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
    • Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.

      • A male or female, who was primed with meningococcal vaccine 134612 or Mencevax™ ACWY in the primary vaccination study 18 months before the first persistence assessment and who completed that study.
      • Written informed consent obtained from the subject/ from the parent or guardians of the subject.
      • Written informed assent obtained from the subject, as applicable, at the time of study entry.
    Exclusion criteria:

      Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aarhus N, Denmark, 8200
    Status
    Study Complete
    Contact us

    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

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-14-05

    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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