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
Study type: Interventional
Phase: Phase 4

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)
    

Detailed description: 
      This multicentre & multicountry study is open and has 2 study groups at Visits 1 and 3
      (HibMenC and LicMenC). An additional control group in the UK at the time of the second year
      follow-up for persistence (subjects aged 40-43 months primed with MenC conjugate and Hib
      vaccines in infancy with no subsequent booster dose, group NoBoost at Visit 2). These
      subjects will receive a Hib catch-up vaccine at 40-43 months of age. The subjects of groups
      HibMenC and LicMenC were randomized in the primary vaccination study 103974 and will not be
      further randomized. The subjects of group NoBoost will not be randomized. All subjects at the
      UK centre will receive Infanrix™-IPV at the second visit (i.e. 24 months after Menitorix
      booster or at 40-43 months of age). In addition, the subjects of group NoBoost will receive a
      Hib catch-up vaccine (Menitorix™) at the same visit.

      Subjects of groups HibMenC and LicMenC will have 3 blood samples taken for immunogenicity
      analyses: at 12, 24 & 48 months after the booster vaccination. Subjects of group NoBoost will
      have 1 blood sample taken for immunogenicity analyses at 40-43 months of age. 75 new subjects
      will be enrolled in this study (group NoBoost).
    

Intervention name(s): Menitorix; Infanrix IPV
Intervention type(s): Biological; Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: antibody persistence; Meningococcal serogroup C vaccine; conjugate vaccine; Haemophilus influenzae type b vaccine