Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Diphtheria
Intervention: Infanrix™; Hiberix™
Intervention description: Intramuscular injection, one dose; Intramuscular injection, one dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 467.0
Sex: All
Minimum age: 18 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infanrix/Hib; Chinese children

Summary:

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals'
      DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to
      24 months of age, in terms of safety and immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Subjects should have completed the full three-dose primary vaccination course in study
             104567.

          -  A male or female child between, and including, 18 and 24 months of age at the time of
             the booster 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.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding booster vaccination, or planned use during
             the study period.

          -  Chronic administration (defined as more than 14 days) 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
             vaccination, or planned administration during the study period, with the exception of
             measles or combined measles, mumps and rubella (MMR) vaccination.

          -  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.

          -  Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus
             influenzae type b diseases since the end of the primary study.

          -  History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b
             diseases.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine(s).

          -  Major congenital defects or serious chronic illness.

          -  History of any progressive neurological disorders or seizures.

          -  Acute disease and/or fever at time of enrolment.

          -  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 any of the following adverse events (AEs) after previous administration
             of a diphtheria-tetanus-pertussis (DTP) vaccine:

               -  Hypersensitivity reaction due to any component of the vaccine.

               -  Encephalopathy.

               -  Fever ≥ 40.0 °C (axillary temperature) within 48 hours of vaccination.

               -  Collapse or shock-like state within 48 hours of vaccination.

               -  Persistent, inconsolable crying occurring within 48 hours of vaccination and
                  lasting ≥ 3 hours.

               -  Seizures with or without fever occurring within 3 days of vaccination.