Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

Exclusion criteria

• ✕. History of any meningococcal B 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;
• ✕. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥38°C) within the previous day;
• ✕. Antibiotics within 6 days prior to enrollment;
• ✕. Pregnancy or nursing (breastfeeding) mothers;
• ✕. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 7 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
• ✕. Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).