Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

Inclusion Criteria:

- Subjects' parent(s)/ Legally Acceptable Representative(s) (LARs) who, in the opinion
of the investigator, can and will comply, with the requirements of the protocol.

- A male or female between, and including, 6 and 12 weeks of age at the time of the
first vaccination.

- Born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed
weeks [259 to 293 days]).

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

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

- Infants who have not received a previous dose of hepatitis B vaccine or those who have
received only 1 dose of hepatitis B vaccine administered at least 30 days prior to
enrolment.

Exclusion Criteria:

- Child in care

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of study vaccines, or planned
use during the study period.

- Chronic administration (defined as more than 14 days in total) of immunosuppressants
or other immune-modifying drugs since birth. For corticosteroids, this will mean
prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.

- Planned administration/administration of a vaccine not foreseen by the study protocol
within the period starting from 30 days before the first vaccination until 30 days
after Dose 3 (Epoch 001, primary vaccination) and from 30 days before the booster Dose
4 until 30 days after booster Dose 4 (Epoch 002, booster vaccination), i.e. the end of
the study:

- Inactivated influenza and hepatitis A vaccines are allowed throughout the study.

- Routine administration(s) of vaccines are allowed from 30 days after the last
dose of primary vaccination until 30 days before the booster dose and after
post-booster blood sampling. Routine administration of measles-mumps-rubella
vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last
dose of primary vaccine until 30 days before booster dose and from post-booster
blood sampling, as well as according to the recommended immunization schedule in
US.

- 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).

- History of Hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus
and hepatitis B diseases.

- Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus,
rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

- Family history of congenital or hereditary immunodeficiency.

- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines (including yeast).

- Hypersensitivity to latex.

- Major congenital defects or serious chronic illness.

- History of any neurological disorders including seizures.

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.

- History of intussusception or of any uncorrected congenital malformation of the
gastrointestinal tract that would predispose the infant to intussusception.

- History of Severe Combined Immunodeficiency Disease (SCID).

- Acute disease and/or fever at the time of enrolment.

- Fever is defined as temperature ≥38.0°C /100.4°F by any route. The preferred
route for recording temperature in this study will be rectal for Epoch 001 and
axillary for Epoch 002.

- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory
infection) without fever may, be enrolled at the discretion of the investigator.