The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers

Inclusion Criteria

All subjects must satisfy the following criteria for the persistence phase of the study entry:

• A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081.
• Written informed consent obtained from parents/guardian of the subject.
• Healthy subjects as established by medical history before entering into the study.
• Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).

All subjects must meet the following criteria prior to receiving the booster vaccination:

• Written informed consent obtained from parents/guardian of the subject.
• Subjects who can and will comply with the requirements of the protocol.
• Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081.

All subjects must satisfy the following criteria prior to enrollment in the naïve control group:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female between, and including, 5-6 years of age at the time of the vaccination.
• Written informed consent obtained from parents/guardian of the subject.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.

Exclusion Criteria

Exclusion criteria for persistence study entry

• Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
• Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
• History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination (no laboratory testing is required).
• Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
• Concurrently participating in another clinical study within 30 days of each persistence timepoint, 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.
• Subjects withdrew consent to be contacted for follow-up studies.

Exclusion criteria for primary (naive control)/booster vaccination at year 5 study entry (to be checked at Year 5)

• Child in care.
• Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled.
• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the primary (naive control)/booster 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 the primary (naive control)/booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
• Vaccination with meningococcal polysaccharide or conjugate vaccine outside of study with NCT number=00471081.
• History of any meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
• Administration of immunoglobulins and/or any blood products within the three months preceding the primary (naive control)/booster vaccination or planned administration during the study period.
• 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 p