Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

• Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
• Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: Prior booster vaccination (At Month 0) ] [ Designated as safety issue: No ]
• Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]

• Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
• Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
• Immunogenicity with respect to components of the study vaccine in terms of booster response to Bordetella pertussis [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
• Serious adverse events [ Time Frame: From the booster dose up to study end (From Day 0 to Month 1) ] [ Designated as safety issue: No ]
• Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
• Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]

• Immunogenicity with respect to the components of the study vaccines (on secondary read-out) [ Time Frame: Prior to and one month after booster vaccination ] [ Designated as safety issue: No ]
• Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
• Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
• Serious adverse events [ Time Frame: From the booster dose up to study end ] [ Designated as safety issue: No ]

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

• Haemophilus Influenzae Type b
• Poliomyelitis
• Hepatitis B
• Diphtheria
• Pertussis
• Tetanus

• Biological: GSK2036874A vaccine
  Intramuscular, single dose
• Biological: Zilbrix™/Hib vaccine
  Intramuscular, single dose
• Biological: Poliorix™
  Intramuscular, single dose

• Experimental: Group A
  Subjects will receive formulation 1 of GSK2036874A vaccine.
  Intervention: Biological: GSK2036874A vaccine
• Experimental: Group B
  Subjects will receive formulation 2 of GSK2036874A vaccine.
  Intervention: Biological: GSK2036874A vaccine
• Experimental: Group C
  Subjects will receive formulation 3 of GSK2036874A vaccine.
  Intervention: Biological: GSK2036874A vaccine
• Active Comparator: Control Group
  Subjects will receive Zilbrix™/Hib and Poliorix™.
  Interventions:

  • Biological: Zilbrix™/Hib vaccine
  • Biological: Poliorix™

Inclusion Criteria:

• A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
• Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
• 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.
• History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• History of neurologic disorders or seizures.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Child in care.

• Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

  • encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
  • fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
  • collapse or shock-like state within 48 hours of vaccination,
  • convulsions with or without fever, occurring within 3 days of vaccination.

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

  • Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
  • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
• Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.