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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This multicenter study is open. No vaccine will be administered during this persistence phase
      of the study. The subjects were randomized in the primary vaccination study 107005 and will
      not be further randomized in this study.
    

Intervention name(s): MenitorixTM; Pneumococcal conjugate vaccine GSK1024850A; PrevenarTM; MeningitecTM; NeisVac-CTM; InfanrixTM hexa; InfanrixTM penta; InfanrixTM IPV/Hib; InfanrixTM IPV
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Conjugate vaccines; Meningococcal serogroup C vaccine; Antibody persistence; Pneumococcal vaccine; Haemophilus Influenzae type b vaccine