Last updated: 11/03/2018 00:24:11

Safety, reactogenicity & immunogenicity study to evaluate a booster dose of GSK Biologicals’ Hib-MenC given with Priorix™ in toddlers (13–14 m) primed with 3 doses of Hib and MenC-CRM197

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GSK study ID
103954
See study documents
Clinicaltrials.gov ID
NCT00263653
EudraCT ID
2004-003275-37
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: Study to evaluate the safety, reactogenicity & immunogenicity of a booster dose of GSK Biologicals’ Hib-MenC given with Priorix™, vs Hib-MenC or Priorix™ only, in toddlers (13–14 m) primed with 3 doses of Hib (as part of a DTPa –containing vaccine) & MenC-CRM197 conjugate vaccines.
Trial description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa –containing vaccine) and MenC-CRM197.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Any grade 3 solicited symptoms (d 0 – 3)

Timeframe: Not applicable

Secondary outcomes:

Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion

Timeframe: Not applicable

Interventions:
  • Biological/vaccine: Haemophilus influenzae type b- and meningococcal (vaccine)
    • Enrollment:
    297
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Carmona A et al. (2010) Reactogenicity and immunogenicity of combined Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine booster dose coadministered with measles, mumps, and rubella vaccine. Pediatr Infect Dis J. 29(3):269-271.
    Medical condition
    Haemophilus influenzae type b, Neisseria Meningitidis
    Product
    SB811936
    Collaborators
    Not applicable
    Study date(s)
    March 2005 to September 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    13 - 14 months
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy male or female between, and including, 13 and 14 months of age.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy male or female between, and including, 13 and 14 months of age.
    • Previously completed 3-dose primary vaccination with a MenC-CRM197 vaccine, and Hib (given as part of a combined DTPa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry. Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period.
    • Previous vaccination against OR history of H. influenzae type b (Hib) and/or meningococcal serogroup C disease and/or measles, mumps or rubella OR known exposure to measles, mumps or rubella within 30 days prior to the start of the present study.
    • 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.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Sevilla, Spain, 41013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pamplona, Spain, 31008
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sant Adriá de Beyós, Barcelona, Spain, 08930
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aravaca, Spain, 28023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mollet del Valles/Barcelona, Spain, 08100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Almería, Spain, 04009
    Status
    Study Complete
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    Showing 1 - 6 of 16 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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-23-09

    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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