Last updated: 11/02/2018 23:16:56

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

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GSK study ID
100791
Clinicaltrials.gov ID
NCT00317187
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: Partially blinded study to assess reactogenicity & safety of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in healthy infants after a hepatitis B birth dose
Trial description: The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

Timeframe: Days 0-3 post dose 1

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

Timeframe: Days 0-3 post dose 2

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

Timeframe: Days 0-3 post dose 3

Secondary outcomes:

Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose

Timeframe: Days 0-3 after each dose

Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose

Timeframe: Day 0-30 after each dose

Occurrence of serious adverse events during the entire study period

Timeframe: Day 0 up to Month 5

Interventions:
  • Biological/vaccine: Tritanrix-HepB/Meningitec conjugate vaccine
  • Biological/vaccine: Tritanrix/Hiberix vaccine
    • Enrollment:
    500
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis B, Diphtheria, Whole Cell Pertussis, Tetanus, Haemophilus influenzae type b
    Product
    SB759346
    Collaborators
    Not applicable
    Study date(s)
    June 2004 to January 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    56 - 83 days
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion criteria:

      • Healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks & has received a birth dose of hepatitis B vaccine within the first 3 days of life. Exclusion criteria:
      • Any confirmed immunodeficient condition, based on medical history and 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 (defined as more than 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.
      • History of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth.
      • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-16-01

    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

    Additional information
    Not applicable
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