One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

Exclusion Criteria

• •Subjects whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study;
• •History of any meningococcal B vaccine administration;
• •Previous ascertained or suspected disease caused by N. meningitidis;
• •For whom parent(s)/legal guardian(s) have given written informed consent according to local regulations after the nature of the study has been explained;
• •History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
• •Antibiotics treatment within 6 days prior to enrolment;
• •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
• •Any serious chronic or progressive disease
• •Known or suspected impairment/ alteration of the immune system,
• •Receipt of, or intent to immunize with another vaccine, within 30 days prior and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
• •Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38C within the previous day;
• •Family members and household members of research staff;
• •Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
• •Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrolment (use of low or moderate doses of inhaled steroids is not an exclusion);
• •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrolment;
• •Participation in another clinical trial within 90 days prior to enrolment or planned for during study;
• •Receipt of, or intent to immunize with any other vaccine(s) within 30 days prior to enrolment (exception: flu-vaccines should not be administered within 14 days prior to enrolment);
• •Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.