Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Condition: Acellular Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Type b
MeSH terms: Diphtheria
Intervention: Infanrix+Hib™; Poliorix™
Intervention description: Intramuscular, one dose; Intramuscular, one dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 831.0
Sex: All
Minimum age: 18 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: combination vaccine; booster vaccination

Summary:

      The purpose of this booster study is to evaluate the immune persistence in healthy Chinese
      subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib)
      vaccine. The study will also evaluate the safety and immune response of these subjects to a
      booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

      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 = NCT01086423).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female child between, and including, 18 and 24 months of age at the time of
             the booster vaccination.

          -  Subjects who completed the full three-dose primary vaccination course in study
             NCT01086423.

          -  Subjects who the investigator believes that their parent(s)/ Legally Acceptable
             Representative(s) LAR(s) can and will comply with the requirements of the protocol

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Child in care

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding the booster dose of the 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
             the booster vaccination, or planned administration during the study period.

          -  Participation in another clinical study within three months prior to enrolment in the
             present booster study or at any time during the present booster study, in which the
             subject has been or will be exposed to an investigational or a non-investigational
             product.

          -  Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus
             influenzae type b, vaccination or disease since the conclusion visit of primary study
             NCT01086423.

          -  Serious chronic illness.

          -  Administration of immunoglobulins and/or any blood products within the 90 days
             preceding the booster dose of study vaccine or planned administration during the study
             period.

          -  Occurrence of any of the following adverse events after a previous administration of a
             DTP vaccine.

          -  Encephalopathy

          -  Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due
             to another identifiable cause.

          -  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.

        The following condition is temporary or self-limiting, and a subject may be vaccinated once
        the condition has resolved if no other exclusion criteria is met:

          -  Acute disease and/or fever at the time of enrolment.