Last updated: 11/06/2018 23:23:17

Immunogenicity & safety study of a vaccine against meningitis in infants (2,4,6 months) after a hepatitis B birth dose.

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GSK study ID
100480
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Clinicaltrials.gov ID
NCT00317161
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: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose
Trial description: The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: DTPw-HBV/Hib-MenAC conjugate vaccine
    • Enrollment:
    1000
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kerdpanich A et al (2008) Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C conjugate combined vaccine is well tolerated and safe. Int J Infect Dis 12 (1): 88-97.
    Medical condition
    Diphtheria, Hepatitis B, Haemophilus influenzae type b, Whole Cell Pertussis, Tetanus
    Product
    SB759346
    Collaborators
    Not applicable
    Study date(s)
    August 2004 to April 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    56 - 83 days
    Accepts healthy volunteers
    Yes
    • Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history & physical examination.
    • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
    Inclusion and exclusion criteria
    Inclusion criteria:

      Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.

    Exclusion criteria:

      Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history & physical examination.

      • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
      • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
      • Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
      • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
      • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Songkla, Thailand, 90110
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Khon Kaen, Thailand, 40002
    Status
    Study Complete
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    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
    2005-10-04

    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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