A study to compare the immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed 1-dose Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy infants

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

• A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
• Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term (i.e., after a gestation period from 37 to 42 weeks).

Child in care.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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. Inhaled and topical steroids are allowed.
• Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
• Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions:
• 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
• Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae.
• History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• 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.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
• Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
• Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.