Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
Condition: Haemophilus Influenzae Type b; Tetanus; Hepatitis B; Whole Cell Pertussis; Diphtheria; Poliomyelitis Vaccines
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: GSK2036874A vaccine; Zilbrix™/Hib vaccine; Poliorix™
Intervention description: Intramuscular, single dose; Intramuscular, single dose; Intramuscular, single dose
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 312.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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.