A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

Exclusion Criteria

• •1. Individuals whose parent(s)/legal guardian(s) are unwilling or unable to give written informed consent to participate in the study;
• •2. Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study.
• •3. History of any meningococcal B vaccine administration;
• •4. Previous ascertained or suspected disease caused by N. meningitidis;
• •5. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis;
• •6. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
• •7. Significant acute or chronic infection within the previous 7 days or temperature 38° C within the previous day of receiving the study vaccine;
• •8. Antibiotics treatment within 6 days prior to enrollment;
• •9. Individuals with history of allergy to vaccine components.
• •10. 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, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
• •11. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of high dose systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 14 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
• •12. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
• •13. Receipt of, or intent to immunize with, any other vaccine(s) within 7 days prior to enrollment.
• •14. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
• •15. Family members and household members of research staff
• •16. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
• •17. History of any meningococcal C vaccine administration (Only applicable to group V and VI).
• •18. History of any Pneumococcal vaccine administration (Only applicable to group V and VI).