Woman and Man
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Extract
To demonstrate immunologic non-inferiority of two doses of two different formulations of rMenB with OMV + MenACWY to a single dose of Menveo, as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W-135 and Y, at 30 days after the last vaccination, in healthy adolescent and young adults aged 10 - 25 years.
Inclusion criteria
- Evaluation of two doses of two investigational rMenB(+OMV)+MenACWY combination vaccine formulations given at a 0, 2 month schedule to demonstrate that the safety and immunogenicity of the combination vaccine are at least comparable to that of the licensed vaccine, Menveo and to that of rMenB+OMV alone. In addition, this study will provide estimates of the immune response rates to the MenB components of the combination vaccines in order to enable a more appropriate design of Phase 3 studies