Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Intervention: Haemophilus influenzae type b- and meningococcal (vaccine); Infanrix™ penta; Infanrix™ hexa; Engerix-B; NeisVac-C™; Infanrix™ IPV/HIB; Meningitec™
Intervention description: Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age; Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).; Intramuscular injection into the thigh as a birth dose; Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.; Intramuscular injection into the thigh as primary vaccination at 4 months of age; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Intervention MeSH terms: PENTA
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 31 Months
Maximum age: 33 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: H.influenzae type b Disease

Summary:

      This protocol posting deals with objectives & outcome measures of the extension phase at
      Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary
      phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives
      & outcome measures of the Booster phase/study are presented in a separate protocol posting
      (NCT number =NCT00323050).

      The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib
      antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol.

          -  A male or female in their third year of life at the time of the study initiation for
             the subjects who enter the study at Visit 1. The subjects who enter the study at Visit
             2 should be in their fourth year of life at the time of the study initiation.

          -  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 Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097
             (NCT=00323050).

          -  Subjects who are part of the Meningitec™ control group and who were not enrolled at
             Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination
             study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a
             fourth dose of Meningitec™ in their second year of life, after the booster study
             Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

        Exclusion Criteria:

          -  Previous administration of a booster dose of Hib or meningococcal serogroup C except
             booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects
             who received a 4th dose of Meningitec™ should be included in the study.

          -  History of H. influenzae type b, meningococcal serogroup C diseases.