Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
Condition: Acellular Pertussis; Hepatitis B; Haemophilus Influenzae Type b; Tetanus; Diphtheria; Poliomyelitis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix hexa; Prevenar 13; GSK217744
Intervention description: Single dose, licensed formulation, intramuscular into right thigh; Single co-administered dose, intramuscular into left thigh; Single dose, investigational formulation A or B, intramuscular into right thigh
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 657.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the
      booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15
      months of age, and the immune persistence following the primary series. All children in this
      booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948
      (NCT01248884). No new subjects will be enrolled in this booster study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who participated in the study 113948 (NCT01248884) and received three doses
             of the new or licensed DTPa-HBV-IPV/Hib study vaccine.

          -  A male or female child between, and including, 12 and 15 months of age at the time of
             the booster vaccination.

          -  Subjects who the investigator believes that parent(s)/ Legally Acceptable
             Representative(s) (LAR(s)) can and will comply with the requirements of the protocol
             (e.g. completion of the diary cards, return for follow-up visit).

          -  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 (drug or vaccine) other than the
             study vaccines 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
             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 (pharmaceutical product or device).

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B,
             poliomyelitis and Hib vaccination or disease since the conclusion visit of study
             113948 (NCT01248884).

          -  Serious chronic illness.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  History of any neurological disorders or seizures.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the booster dose of study vaccine or planned administration during the study
             period.

          -  Occurrence of any of the following events following previous administration of the
             study vaccine constitutes an absolute contraindication to further dosing.

               -  Anaphylactic or other hypersensitivity reaction.

               -  Encephalopathy defined as an acute, severe central nervous system disorder
                  occurring within 7 days following vaccination and generally consisting of major
                  alterations in consciousness, unresponsiveness, generalized or focal seizures
                  that persist more than a few hours, with failure to recover within 24 hours.

               -  Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of
                  vaccination, not due to another identifiable cause.

               -  Collapse or shock-like state (hypotonic-hyporesponsive episode) 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.

          -  Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥
             38.0° on rectal setting.

          -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
             infection) without fever may, be enrolled at the discretion of the investigator.