Last updated: 11/07/2018 01:05:51

Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

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GSK study ID
105239 (mth24-30)
See study documents
Clinicaltrials.gov ID
NCT00291343
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: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Trial description: This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serum bactericidal activity against Neisseria meningitidis serogroups A, C (rSBA-MenA, C) using rabbit complement antibodies

Timeframe: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).

Secondary outcomes:

Number of subjects with anti-rSBA-MenA, C antibody titers ≥ pre-defined cut-off values

Timeframe: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

Anti-rSBA-MenA, C antibody titers

Timeframe: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

Number of subjects with anti-pilysaccharide A and C (anti-PSA/PSC) antibody concentrations ≥ predefined cut-off values

Timeframe: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

Anti-PSA, anti-PSC antibody concentrations

Timeframe: Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination.

Number of subjects with anti-hepatitis B surface (anti-HBs) antigen antibody concentrations ≥ cut-offs

Timeframe: Prior to the Mencevax ACWY vaccination at 24-30 Months of age

Anti-HBs concentrations

Timeframe: Prior to the Mencevax ACWY vaccination at 24-30 Months of age

Number of subjects with vaccine response for rSBA-Men A, C

Timeframe: 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age).

Number of subjects with solicited local symptoms

Timeframe: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age

Number of subjects with solicited general symptoms

Timeframe: During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age

Number of subjects with unsolicited adverse events (AEs)

Timeframe: From Day 0 at months 15-24 of age to study end at Months 25-31 of age

Number of subjects with serious adverse events (SAEs)

Timeframe: From 15-24 Months of age up to Months 25-31 of age

Interventions:
  • Biological/vaccine: Tritanrix™- HepB
  • Biological/vaccine: Hiberix™
  • Biological/vaccine: Mencevax™ ACWY
    • Enrollment:
    296
    Primary completion date:
    2007-15-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Meningococcal
    Product
    SB759346
    Collaborators
    Not applicable
    Study date(s)
    February 2006 to March 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    15 - 24 months
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria: -Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
    • A male or female between, and including, 15 and 24 months of age at the time of vaccination.
    • 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 participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329. Exclusion criteria:
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination; with the exception of oral poliovirus vaccine (OPV).
    • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
    • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
    • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • A family history of congenital or hereditary immunodeficiency.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • Major congenital defects or serious chronic illness.
    • History of any neurologic disorders or seizures including febrile seizures in infancy.
    • Acute disease at the time of enrolment.
    • Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Sampaloc, Manila, Philippines, 1008
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Manila, Philippines, 1000
    Status
    Study Complete
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-15-03
    Actual study completion date
    2007-15-03

    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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