Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose

Exclusion Criteria

• •1. If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.
• •2. Subject is a pregnant or breast-feeding female.
• •3. Subjects' parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.
• •4. History of documented or suspected invasive meningococcal disease.
• •5. Previous household contact with and/or intimate exposure to an individual with laboratory proven N. meningitidis infection within 60 days prior to enrollment and for the duration of the study.
• •6. Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have not received any meningococcal vaccine since birth.
• •7. Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.
• •8. Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.
• •9. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
• •10. Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• •11. Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents or systemic corticosteroids for at least seven days at any dose in the past 12 weeks or planned use throughout the study period (nasal or inhaled steroids are permitted, as are steroids applied to the skin).
• •12. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the past 12 weeks or planned use throughout the study period.
• •13. Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.
• •14. Subjects participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the study period.
• •15. Subjects who have experienced a significant acute infection requiring systemic antibiotic treatment within the 5 days prior to enrolment or have experienced a body temperature ≥38°C (≥100.4°F) within the 3 days before the intended study vaccination.
• •16. Any condition which, in the opinion of the investigator, would pose a health risk to the participant.