The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix™-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Primary Outcome Measures:
- 1M post 4th dose of study vaccine & applicable control: SBA-MenC/A≥128, anti-PRP≥1. 1M post Mencevax booster in subjects primed with MenAC conjugate: SBA-MenC/A≥128.
Secondary Outcome Measures:
- Pre and 1M post each vacc dose: antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered. Loc/gen symp: D 0-3, unsol symp: D 0-30 post each vac. SAE for entire study.
| Estimated Enrollment: |
1000 |
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax™ ACWY phase at 24-30 months a dose of Mencevax™ ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax™ ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.