Last updated: 11/04/2018 04:05:15

study to evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT and Hib-MenC-TT or Meningitec™ in healthy toddlers

Request patient level data
GSK study ID
711202/008
See study documents
Clinicaltrials.gov ID
NCT00135564
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: Evaluate the persistence and immune memory induced by a primary vaccination course with GSK Biologicals’ MenC-TT (1 formulation) & GSK Biologicals’ Hib-MenC-TT (2 formulations) or Meningitec™ in healthy toddlers aged 12-15 months primed in study 711202/001
Trial description: The purpose of this booster vaccination study is to evaluate the persistence and immune memory induced by a three-dose primary vaccination course with GSK Biologicals’ MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) and GSK Biologicals’ Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) or Meningitec™ vaccines in healthy toddlers aged 12-15 months by giving them a 1/5th dose of Mencevax™ ACWY.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: MenC-TT
  • Biological/vaccine: Hib-MenC-TT
    • Enrollment:
    500
    Primary completion date:
    2003-31-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Schmitt et al, Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine (2007) Clin Vaccine Immunol, 14 (4): 426–434.
    Schmitt HJ et al. (2007) Immunogenicity, Reactogenicity, and Immune Memory after Primary Vaccination with a Novel Haemophilus influenzae-Neisseria meningitidis Serogroup C Conjugate Vaccine. Clin Vaccine Immunol. 14(4):426–434.
    Medical condition
    Infections, Meningococcal
    Product
    Meningococcal Vaccine
    Collaborators
    Not applicable
    Study date(s)
    January 2003 to July 2003
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 15 months
    Accepts healthy volunteers
    Yes
    • Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment
    • Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
    • Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy toddlers (12-15 m) with at least 1 dose of the 3-dose vaccination course of MenC or Hib-MenC vaccine in study 711202/001, OR without previous vaccination against MenC disease but with completed primary vaccination according to the German Standing Committee on Immunization (STIKO) recommendation at least 6 months before enrolment
    Exclusion criteria:
    • Previous/intercurrent booster vaccination against OR history of OR exposure to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
    • Planned administration/administration of a vaccine within 30 d preceding study vaccination and until study end with the exception of Infanrix hexa®.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
    • A family history of congenital or hereditary immunodeficiency.
    • History of any neurologic disorders or seizures, of allergic disease/reactions likely to be exacerbated by any component of the vaccines

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    Actual primary completion date
    2003-31-07
    Actual study completion date
    2003-31-07

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website