Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Condition: Tetanus; Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Poliomyelitis; Acellular Pertussis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Intervention: GSK2202083A vaccine; Infanrix hexa™; Menjugate™; NeisVac-C™; Synflorix™
Intervention description: Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.; Intramuscular, one dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 391.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: booster vaccination; combined vaccine

Summary:

      The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A
      vaccine when administered as a booster dose following priming in the first year of life with
      the same 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 = NCT00970307).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/ legally acceptable
             representative(s) can and will comply with the requirements of the protocol.

          -  Subjects who have completed the full three-dose primary vaccination course according
             to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).

          -  A male or female between, and including, 12 and 18 months of age at the time of
             booster vaccination.

          -  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:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the 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 vaccination.

          -  Planned administration/administration of immunoglobulins and/or any blood products
             within three months before the booster dose, or during the study period.

          -  Planned administration/administration of any vaccine not foreseen by the study
             protocol during the period starting 30 days before and ending 30 days after the
             booster dose.

          -  Participation in another clinical study since the primary study
             DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an
             investigational or a non-investigational product.

          -  Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib,
             pneumococcal and MenC vaccination or disease since the conclusion visit of study
             DTPa-HBV-IPV/Hib-MenC-TT-002.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines.

          -  The following adverse event having occurred after previous administration of DTP
             vaccine:

               -  Encephalopathy.

               -  Temperature of >= 40.5°C (rectal 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.

          -  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.