Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.

Inclusion criteria

• Adolescents 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has given written informed consent at the time of enrollment;
• Available for all the visits scheduled in the study (i.e. not planning to leave the area before the end of the study period);
• In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
• With a negative urine pregnancy test (for female subjects only).

Exclusion criteria

• History of any meningococcal vaccine administration;
• Current or previous, confirmed or suspected disease caused by N. meningitidis;
• Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
• Pregnancy or nursing (breastfeeding) mothers;
• Female subjects who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study;
• Any serious chronic or progressive disease;
• Family members and household members of research staff;
• Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
• Significant acute or chronic infection within the previous 7 days or fever within 3 days prior to enrolment;
• Antibiotics within 6 days prior to enrollment;
• Known or suspected impairment/alteration of the immune system, immunosuppressive therapy;
• 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;
• Receipt of or intent to immunize with any other vaccine(s) within 30 days prior and throughout the study period;
• Participation in another clinical trial within the last 90 days or planned for during study.