Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

- Experimental design: Phase IIIA, observer-blind, randomised (1:1:1:1), controlled,
multi-centric, with four parallel groups and a staggered enrolment (Part A and Part B).

- Duration of the study: The intended duration of the study, per subject, will be
approximately 7-8 months including the 6 months of extended safety follow-up period
after the last dose of HRV vaccine.

- Epoch 001: Primary starting at Visit 1 (Day 0) and ending at the safety follow-up
contact (Month 7-8).

- Primary completion Date (PCD): Visit 3 (Month 2-4).

- End of Study (EoS): Last testing results released of samples collected at Visit 3 or
Last Subject Last Visit (LSLV) (Follow up contact at month 7-8).

- Study Groups:

- PCV-free HRV liquid formulation lot A (also referred to as Liq_A Group)

- PCV-free HRV liquid formulation lot B (also referred to as Liq_B Group)

- PCV-free HRV liquid formulation lot C (also referred to as Liq_C Group)

- GSK Biologicals' currently licensed lyophilised HRV formulation (also referred to
as Lyo Group)

- Control:active control-GSK Biologicals' currently licensed lyophilised HRV vaccine

- Vaccination schedule: Two doses of HRV vaccine to be administered according to a 0, 1-2
month schedule according to the immunisation schedule for RV vaccine.

Inclusion Criteria:

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

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

- A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at
the time of the first study vaccination.

- Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6
days).

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

Exclusion Criteria:

- Child in care

- Use of any investigational or non-registered product other than the study vaccines
during the period starting 30 days before the first dose of study vaccines (Day-29 to
Day 0), or planned use during the study period.

- Chronic administration 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.

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

- Administration of long-acting immune-modifying drugs at any time during the study
period.

- Planned administration/administration of a vaccine not foreseen by the study protocol
in the period starting 30 days before the first dose of vaccine administration and
ending at Visit 3, with the exception of the inactivated influenza vaccine, which is
allowed at any time during the study and other licensed routine childhood
vaccinations.

- 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 vaccine/product.

- Uncorrected congenital malformation of the gastrointestinal tract that would
predispose for Intussusception (IS).

- History of IS.

- Family history of congenital or hereditary immunodeficiency.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Major congenital defects or serious chronic illness.

- Previous vaccination against RV.

- Previous confirmed occurrence of RVGE.

- GE within 7 days preceding the study vaccine administration.

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

- Hypersensitivity to latex.

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

- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for
measuring temperature in this study will be the oral cavity, the axilla and the
rectum.

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