A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

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Immunogenicity Objectives ﾷTo explore the immunogenicity of three doses of Novartis rMenB + OMV in healthy at risk adults, by evaluation of the breadth of serum bactericidal activity using human complement (BCA) response against a panel of genetically distinct meningococcal strains, at one month after the administration of the first, the second and the third dose and immediately before the administration of the third dose.ﾷTo explore the immunogenicity of a single dose of Novartis MenACWY conjugate vaccine given to healthy at risk adults, by evaluation of serum bactericidal activity using human complement (BCA) response against N. meningitidis serogroups A, C, W and Y, at one month after vaccination. Safety Objectives ﾷTo explore the safety and tolerability of Novartis rMenB + OMV in healthy at-risk adults when administered at a 0, 2, 6- month schedule, throughout the clinical study.ﾷTo explore the safety and tolerability of a single dose of Novartis MenACWY conjugate vacci

Critère d'inclusion

Prevention Meningitis/Sepsi caused by Meningococcus type B or A, C, W-135, Y

Kusajili – Centralise les essais cliniques mondiaux

A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single d...