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.
"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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
324
GSK Investigational Site
Beirut, Lebanon
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)
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.
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