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

GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate
vaccine has been shown to be well tolerated and immunogenic in toddlers.

The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3
years and 5 years post-administration of one dose or two doses of GlaxoSmithKline (GSK)
Biologicals' meningococcal vaccine GSK134612 when given to healthy toddlers 9-12 months of
age. To evaluate, the safety and immunogenicity of a booster dose of GSK134612 administered
to all eligible subjects at 5 years after the primary vaccination. To evaluate the safety and
immunogenicity in a new group of subjects aged 5-6 years (naive control group) who will
receive a single dose of vaccine GSK134612.

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(i.e., not withdrawn, had received all planned doses of study vaccines, provided a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 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.

- Hypersensitivity to latex.

- Previous administration or planned administration/ administration of a vaccine not
foreseen by the study protocol during the period starting from 30 days of the study
vaccination (primary vaccination for the naïve control group and booster vaccination
for subjects primed in Study with NCT number = 00471081) and ending 30 days after with
the exception of any licensed inactivated influenza vaccine (live attenuated influenza
vaccine is not allowed).

- Previous administration or planned administration of tetanus or any tetanus containing
vaccine during the period starting from 30 days of the study vaccination and ending 30
days after.

- A family history of congenital or hereditary immunodeficiency, until the immune
competence of the potential vaccine recipient is demonstrated.

- 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 neurological disorders or seizures.

- Acute disease at the time of vaccination. (Acute disease is defined as the presence of
a moderate or severe illness with or without fever. All vaccines can be administered
to persons with a minor illness such as diarrhea, mild upper respiratory infection
with or without low-grade febrile illness, i.e., temperature by any method < 99.5°F
(37.5°C).