Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal conjugate vaccine GSK134612
Intervention description: Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 84 Months
Maximum age: 95 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity; Booster; Healthy; Vaccine response; Safety; Neisseria meningiditis; Antibody persistence; Meningococcal conjugate vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a
      booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary
      vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and
      Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the
      long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

      This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the
             investigator, can and will comply, with the requirements of the protocol.

          -  A male or female between, and including, 84 and 95 months of age at the time of the
             booster vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject and written
             informed assent obtained from the subject in accordance with local laws and
             regulations.

          -  Healthy subjects as established by medical history and history-directed physical
             examination before entering into the study.

          -  Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per
             protocol.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥
             0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

          -  Administration of a vaccine not foreseen by the study protocol within the period
             starting 30 days before and ending 30 days after the study vaccine dose, with the
             exception of a licensed inactivated influenza vaccine which can be administered at any
             time during the study according to the local recommendations.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product.

          -  Previous vaccination with meningococcal vaccine except the meningococcal vaccination
             received in the Hib-MenC-TT-016 study.

          -  History of meningococcal disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital
             or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical
             history and physical examination (no laboratory testing required).

          -  Family history of congenital or hereditary immunodeficiency.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine, and history of serious allergic reaction (anaphylaxis) following the
             administration of vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any neurological disorders or seizures, including GBS. History of a simple,
             single febrile seizure is permitted.

          -  Acute disease and/or fever at the time of enrollment.

               -  Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or
                  ≥ 38.0°C for rectal route. The preferred route for recording temperature in this
                  study will be oral.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the study vaccination or planned administration during the booster
             vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months
             preceding the blood sampling at Visit 3.

        The following criteria should be checked for the long-term persistence phase at two years
        after booster vaccination (Visit 3):

        In case an exclusion criterion becomes applicable, the subject will not enter the long-term
        follow-up and the reason will be documented.

          -  Previous administration of a meningococcal vaccine with the exception of the
             meningococcal vaccination given in the primary study and the booster vaccination in
             this particular study.

          -  History of meningococcal disease.