The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.
Primary Outcome Measures:
- 1 month after vaccination, measurement of serum bactericidal titers against meningococcal serogroups A, C, W135 and Y (SBA-MenA; SBA-MenC; SBA-MenW135 and SBA-MenY)
Secondary Outcome Measures:
- Immuno : the same immuno evaluation performed 1 month after vaccination will also be performed before vaccination; also vaccine response at Post-dose 1.
- Safety : Solicited symptoms during day 0-3, unsol. symptoms during day 0-30 & SAEs during entire study.
| Estimated Enrollment: |
324 |
| Study Start Date: |
June 2005 |
"Randomized study with four groups to receive one of the following vaccination regimens:
- One of the 3 lots of GSK Biologicals’ Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals’ already existing Mencevax™ ACWY