GlaxoSmithKline's (GSK) Safety and Immunogenicity Study of GSK Meningococcal Group B and 13-valent Pneumococcal Vaccines Administered Together With Routine Infant Vaccines in Healthy Infants

This study will be divided into 3 timepoints:

- Epoch 1- Primary- From day 1 to day 301

- Epoch 2-Secondary-From day 301 to day 331

- Epoch 3-Safety follow up -From day 331 to study end (day 661) In addition to receiving
the study vaccines, infants will also receive non-study vaccines such as Diphtheria,
tetanus toxoids and acellular pertussis adsorbed vaccine (DTPa, Infanrix) and
Haemophilus influenzae type b Conjugate Vaccine (Hib, Hiberix), to ease the disruption
to the standard infant vaccine schedule caused by participating in this study.

Inclusion Criteria:

All subjects must satisfy all the following criteria at study entry:

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply, with the requirements of the protocol (e.g.
completion of the eDiary, return for follow-up visits).

- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
performing any study specific procedure.

- A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12
weeks) at the time of the 1st vaccination.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born full-term (i.e. after a gestation period of ≥ 38 weeks).

Exclusion Criteria:

If any exclusion criterion applies, the subject must not be included in the study:

• Child in care

Each subject must not have:

- Progressive, unstable or uncontrolled clinical conditions.

- Hypersensitivity, including allergy to any component of vaccines, medicinal product or
medical equipment whose use is foreseen in this study.

- Hypersensitivity to latex.

- Clinical conditions representing a contraindication to intramuscular vaccination and
blood draws.

- Abnormal function of the immune system resulting from:

- Clinical conditions.

- Systemic administration of corticosteroids (PO/IV/IM) for more than 14
consecutive days from birth.

- Administration of antineoplastic and immunomodulating agents or radiotherapy for
any duration from birth.

- Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic,
muscular, nervous system or skin autoimmune disorders; lupus erythematosus and
associated conditions; rheumatoid arthritis and associated conditions;
scleroderma and associated disorders) or immunodeficiency syndromes (including,
but not limited to: acquired immunodeficiency syndromes and primary
immunodeficiency syndromes).

- Received immunoglobulins or any blood products from birth.

- Received an investigational or non-registered medicinal product from birth.

- Any other clinical condition that, in the opinion of the investigator, might pose
additional risk to the subject due to participation in the study.

- Neuroinflammatory disorders (including but not limited to: demyelinating disorders,
encephalitis or myelitis of any origin), congenital and peripartum neurological
conditions, encephalopathies, seizures (including all subtypes such as: absence
seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple
seizures or febrile convulsions).

- Congenital or peripartum disorders resulting in a chronic condition (including but not
limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis
disorders, cardiac disorders).

- Study personnel as an immediate family or household member.

- Current or previous, confirmed or suspected disease caused by N. meningitidis

- Household contact with and/or intimate exposure from birth to an individual with
laboratory confirmed N. meningitidis and/or Streptococcus pneumoniae infection or
colonization.

- Previous administration of meningococcal B or pneumococcal vaccine at any time prior
to informed consent.

- Received a dose of DTPa-HBV-IPV, HRV, MMR, VV and/or Hib at any time prior to informed
consent. Receipt of one dose of HBV up to 4 weeks prior to informed con-sent is
allowed.

- Serious chronic illness.

- Uncorrected congenital malformation (such as Meckel's diverticulum) of the
gastrointestinal tract that would predispose for Intussusception (IS).