Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal vaccine GSK134612; Meningitec™
Intervention description: One intramuscular dose (Booster); One intramuscular dose (Booster)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 342.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal vaccine GSK134612

Summary:

      Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24
      months after vaccination and the subjects who were vaccinated in the primary study will be
      enrolled in this extension phase. No new subjects will be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent(s)/guardian(s) can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Written informed consent obtained from the parent(s) or guardian(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  A male or female having completed the primary study 109670 and who was primed with the
             investigational or Meningitec™ vaccines.

        Exclusion Criteria:

        Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the subject's first visit.

          -  History of meningococcal disease.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine outside of study 109670.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history.

          -  Administration of immunoglobulins and/or blood products within the three months
             preceding the subjects first visit.

          -  Concurrently participating in another clinical study, within 30 days of study entry,
             in which the subject has been or will be exposed to an investigational or a
             non-investigational product (pharmaceutical product or device).

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

        Additional exclusion criteria for booster vaccination (to be checked at Month 48):

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the booster vaccination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria
             toxin protein and/or tetanus toxoid.

          -  History of hypersensitivity after previous administration of Meningitec or the
             investigational vaccines in study 109670.

          -  Hypersensitivity to latex.

          -  Planned administration/ administration of a vaccine not foreseen by the protocol
             within one month before and 30 days after the booster dose.

          -  Previous vaccination with any component of the vaccines within the last month.

          -  History of any neurological disorder or seizures (one episode of febrile convulsion
             does not constitute an exclusion criteria).

          -  Major congenital defects or serious chronic illness.

          -  Acute disease at the time of vaccination.