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

This is an interventional prevention trial for Haemophilus Influenzae Type b Read More

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.