The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).
The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
478
Meningococcal serogroup B (MenB) immune response (i.e. at least a 4-fold increase in serum bactericidal activity [SBA] from pre-vaccination titer) at 1 month postvaccination for each MenB strain assayed
For each MenB strain assayed, pre and 1m post dose 2 and 3: SBA seropositivity, titer and immune response (post dose 2 only)
After each vaccination: grade 3 and any solicited symptoms (Day 0-14), unsolicited symptoms (Day 0-30)
Serious adverse events [SAEs] (whole study)
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