Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis; Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine
MeSH terms: Influenza, Human; Haemophilus Infections
Intervention: Menitorix; Infanrix IPV
Intervention description: Menitorix was only administered to subjects of the group Meningitic+Hiberix group at 40 to 43 months of age.; Infanrix IPV was administered according to the manufacturer's instructions to UK subjects at 40 to 43 months of age.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 24 Months
Maximum age: 64 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: antibody persistence; Meningococcal serogroup C vaccine; conjugate vaccine; Haemophilus influenzae type b vaccine

Summary:

      The purpose of this study is to evaluate the long-term antibody persistence at 12, 24 and 48
      months after the administration of a booster dose of Menitorix™, given at 12-15 months of
      age. The children had previously received 3 doses of Menitorix™ and Infanrix IPV™ or
      Meningitec™ and Pediacel™ in infancy. In addition, the antibody persistence is to be
      investigated in children of 40-43 months of age who received a 3-dose primary vaccination of
      a MenC conjugate vaccine and a Hib containing vaccine in infancy without a booster dose of
      MenC conjugate and Hib vaccine in the second year of life.

      This protocol posting deals with objectives & outcome measures of the extension phases at 12,
      24 and 48 months after the booster phase. The links to objectives and outcome measures of the
      primary phase & booster phase at 12 to 15 months are provided below:

      https://www.gsk-studyregister.com/study/2747 (Primary phase)
      https://www.gsk-studyregister.com/study/2755 (Booster phase)
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between and including 24 and 31 months of age at the time of Visit 1,
             between and including 40 and 43 months of age at Visit 2 and between and including 60
             and 64 months at Visit 3.

          -  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.

          -  Having completed the booster vaccination study 104056.

        Subjects of group NoBoost at Visit 2 (UK only):

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female between and including 40 and 43 months of age at Visit 2.

          -  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.

          -  Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib
             containing vaccine before the age of 8 months.

        Exclusion Criteria:

          -  Previous administration of booster dose of Hib or meningococcal serogroup C except
             booster study vaccines during the study 104056.

          -  History of H. influenzae type b or meningococcal diseases.

          -  For UK subjects of groups HibMenC and LicMenC only: previous administration of a
             booster dose of a pertussis-containing vaccine except booster study vaccines during
             the study 104056.