Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Tritanrix™- HepB; Hiberix™; Mencevax™ ACWY
Intervention description: One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months; One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months; One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 296.0
Sex: All
Minimum age: 15 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hepatitis B; meningococcal vaccine; pertussis; Prophylaxis diphtheria; meningococcal serogroups A and C diseases; tetanus; Haemophilus influenzae type b

Summary:

      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.
    

Eligibility 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.