Immuno,safety of GSK vaccine 134612 given at age of 12-15 months 15-18 months post-priming with GSK vaccine 792014

Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.

• A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born after 36 weeks gestation.
• For inclusion in the booster phase, subjects must have received all three doses in the primary phase.

Exclusion criteria for enrolment (primary phase)

• 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) of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
• Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
• History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at time of enrollment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Concurrent participation 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). Exclusion criteria for enrolment (booster phase)
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
• Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
• Previous administration of a booster dose of Hib prior to entry to the booster phase.
• Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
• Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
• Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
• History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease at time of enrollment.
• Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
• Concurrent participation 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).