Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Condition: Acellular Pertussis; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b; Tetanus; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix Hexa
Intervention description: Vaccine administered as a booster dose at 16-20 months of age
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 16 Months
Maximum age: 20 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hexavalent vaccine; Booster

Summary:

      The purpose of this booster study is to evaluate, in subjects primed in the primary study
      106786, the persistence, at the time of the booster vaccination, of antibodies elicited by
      the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will
      also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This
      protocol posting deals with the objectives and outcome measures of the booster phase. The
      objectives and outcomes measures of the primary phase are presented in a separate protocol
      posting (NCT = 00376779).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol

          -  Subjects must have completed the full three-dose primary vaccination course with one
             of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.

          -  A male or female between, and including, 16 and 20 months of age at the time of
             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 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 vaccine dose.

          -  Participation in another clinical study, between the primary study 106786 and the
             present booster study, or at any time during the study, in which the subject has been
             or will be exposed to an investigational or a non-investigational product.

          -  Planned administration or administration of a vaccine not foreseen by the study
             protocol during the period starting 30 days before the administration of the booster
             dose and ending 30 days after the booster dose.

          -  Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib
             booster vaccination or disease since the conclusion visit of study 106786.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  Acute disease at the 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.