Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Inclusion Criteria:

• Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.

Exclusion Criteria:

• History of any meningococcal vaccine administration;
• Current or previous, confirmed or suspected disease caused by N. meningitidis;
• Pregnant or nursing (breastfeeding) mothers;
• Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;
• Any serious, chronic, or progressive disease;
• Known or suspected impairment/alteration of the immune system;
• Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.