Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center,
multi-country study with four parallel groups. This study will evaluate the immunogenicity
and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR
vaccine, throughout this document) in contrast to the US standard of care comparator vaccine
(M-M-R II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children
during their second year of life. The first dose of this two-dose study is designed to
establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given
as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a
mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of
these Inv_MMR groups will have a potency within the release range of the marketed vaccine.
The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be
analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered
with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely
administered to children of this age in the US.

Inclusion Criteria:

- Male or female child between 12 and 15 months of age at the time of vaccination.

- The investigator believes that the parent(s) or Legally Acceptable Representative(s)
(LAR(s)) of the child, can, and will comply with the requirements of the protocol.

- Written informed consent obtained from the parent(s)/LAR(s) of the child.

- Child is in stable health as determined by investigator's clinical examination and
assessment of child's medical history.

For US children only:

• Child that previously received a 3-dose series of Prevnar 13 with last dose at least 60
days prior to study entry.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product other than the study vaccine(s)
during the period starting 30 days before the day of study vaccination or planned use
during the entire study period.

- Concurrently participating in another clinical study, in which the child has been or
will be exposed to an investigational or a non-investigational product. Chronic
administration of immunosuppressants, or other immune-modifying drugs during the
period starting 180 days prior to the first vaccine dose or any planned administration
of immunosuppressive and immune-modifying drugs during the entire study.

- Inhaled and topical steroids are allowed.

- Planned administration / administration of a vaccine not foreseen by the study
protocol during the period starting 30 days prior to study vaccination at Visit 1 and
ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please
Note:

- Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate
vaccine (Hib) vaccines may be given at any time during the study, including the
day of study vaccination (Flu and Hib vaccines must be administered at a
different location than the study vaccine/s).

- Any age appropriate vaccine may be given starting at Visit 2 (or starting at
Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.

- Administration of immunoglobulins and/or any blood products during the period starting
180 days prior to study vaccination at Visit 1 or planned administration from the date
of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the
US post-dose 2 sub-cohort.

- History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.

- Known exposure to measles, mumps, rubella and/or varicella/zoster during the period
starting 30 days prior to the first study vaccination.

- Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella
virus.

- 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 vaccines, including hypersensitivity to neomycin, latex or gelatin.

- Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
affecting the bone marrow or lymphatic systems.

- Acute disease at the time of enrollment. Acute disease is defined as the presence of a
moderate or severe illness with or without fever. Fever is defined as temperature
≥38°C/100.4°F by any age appropriate route. All vaccines can be administered to
persons with a minor illness such as diarrhea, mild upper respiratory infection
without fever.

- Active untreated tuberculosis based on medical history.

- Any other condition which, in the opinion of the Investigator, prevents the child from
participating in the study.

For US children only:

• A child that previously received a fourth dose of any pneumococcal conjugate vaccine.