study to evaluate the immunogenicity and reactogenicity of a booster dose of gsk2036874a vaccine in healthy toddlers

Conditions: Haemophilus Influenzae Type b; Tetanus; Hepatitis B; Whole Cell Pertussis; Diphtheria; Poliomyelitis Vaccines

Summary: 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.

Eligibility criteria:
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.