Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Intervention: MenitorixTM; Pneumococcal conjugate vaccine GSK1024850A; PrevenarTM; MeningitecTM; NeisVac-CTM; InfanrixTM hexa; InfanrixTM penta; InfanrixTM IPV/Hib; InfanrixTM IPV
Intervention description: Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.; Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study; Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study; Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study; Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 582.0
Sex: All
Minimum age: 36 Months
Maximum age: 76 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Conjugate vaccines; Meningococcal serogroup C vaccine; Antibody persistence; Pneumococcal vaccine; Haemophilus Influenzae type b vaccine

Summary:

      This protocol posting deals with objectives & outcome measures of an extension phase when
      subjects are aged 3, 4 and 6 years of age. The objectives & outcome measures of the primary
      phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives
      & outcome measures of the booster phase are presented in a separate protocol posting (NCT
      number = NCT00463437).

      The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal
      serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are
      aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 36 and 40 months of age at the time of Visit
             1; between, and including, 48 and 52 months of age at the time of Visit 2; and
             between, and including, 72 and 76 months of age at the time of 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.

          -  Subjects who previously participated in the primary and booster studies, who received
             a full vaccination course with the vaccines corresponding to their group during the
             primary and booster studies and who were part, in the booster study, of the blood
             sampling subset.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the first blood sampling.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Administration of any additional meningococcal serogroup C, Hib, hepatitis B and
             pneumococcal vaccine since the end of the booster study

          -  History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and
             invasive pneumococcal diseases since the end of booster study.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition since the
             end of booster study, based on medical history and physical examination (no laboratory
             testing required).

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the first blood sampling.