Last updated: 11/03/2018 09:48:56

Long-Term Antibody Persistence at 1, 3 and 5 Years After a fourth dose of GSK Biologicals' Hib-MenCY-TT Vaccine compared to ActHIB

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GSK study ID
107824
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Clinicaltrials.gov ID
NCT00359983
See results summary
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 study to evaluate the long-term antibody persistence at 1, 3 & 5 years after the administration of a fourth dose of Hib-MenCY-TT Vaccine compared to ActHIB in subjects boosted in a previous study.
Trial description: This study is evaluating antibody persistence at 1, 3 & 5 years post-fourth dose (i.e., at 2, 4 & 6 years of age, respectively) in subjects vaccinated in a previous study.
This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3 and 5. The objectives & outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).
This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with anti- Polyribosylribitol phosphate (anti-PRP) antibody concentrations greater than or equal to 0.15 microgram per milliliter

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Number of subjects with Neisseria meningitidis serogroup C (MenC) antibody titers greater than or equal to 1:8 as measured by serum bactericidal assay using human complement (hSBA)

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Number of subjects with Neisseria meningitidis serogroup Y (MenY) antibody titers greater than or equal to 1:8 as measured by serum bactericidal assay using human complement (hSBA)

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Secondary outcomes:

Anti-PRP Geometric Mean Concentrations (GMCs)

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Number of subjects with anti-PRP antibody concentrations greater than or equal to 1.0 microgram per milliliter

Timeframe: One year, three years, and five years after the fourth dose vaccination.

hSBA-MenC Geometric Mean Titers (GMTs)

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Number of subjects with hSBA-MenC titers greater than or equal to 1:4

Timeframe: One year, three years, and five years after the fourth dose vaccination.

hSBA-MenY Geometric Mean Titers (GMTs)

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Number of subjects with hSBA-MenY titers greater than or equal to 1:4

Timeframe: One year, three years, and five years after the fourth dose vaccination.

Interventions:
  • Biological/vaccine: MenHibrix (Hib-MenCY-TT)
  • Biological/vaccine: Hib conjugate vaccine (ActHIB)
    • Enrollment:
    270
    Primary completion date:
    2007-07-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines.10(7):941-950.
    Marshall GS et al. (2010) Immune response and one year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y–tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 29(5): 469-471.
    Marshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.
    Marshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.
    Medical condition
    Neisseria Meningitidis, Haemophilus influenzae type b
    Product
    SB792014
    Collaborators
    Not applicable
    Study date(s)
    September 2006 to November 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    22 - 60 months
    Accepts healthy volunteers
    Yes
    • Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
    • ­ Year 1: 22 to 36 months of age.
    • Children should not have:
    • received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
    Inclusion and exclusion criteria
    Inclusion criteria:

      Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows: ­ Year 1: 22 to 36 months of age. ­ Year 3: 44 to 60 months of age. ­ Year 5: 5 years post-dose 4 +/- 8 weeks

      • Written informed consent obtained from the parent or guardian of the subject.
      • Healthy subjects as established by medical history and clinical examination before entering into the study
      • Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006
    Exclusion criteria:
    • Children should not have:
    • received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
    • had a history of H. influenzae type b, meningococcal serogroup C and Y diseases

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bossier City, Louisiana, United States, 71111
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30062
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bardstown, Kentucky, United States, 40004
    Status
    Study Complete
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    Showing 1 - 6 of 21 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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-07-11
    Actual study completion date
    2007-07-11

    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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