Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

Exclusion Criteria

• •1. History of any meningococcal vaccine administration.
• •2. Previous known or suspected disease caused by N. meningitidis.
• •3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
• •4. History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.
• •5. Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38.0°C within the previous 3 days.
• •6. Individuals who have received antibiotics within 6 days before vaccination.
• •7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
• •* Receipt of any immunosuppressive therapy at any time since birth.
• •* Receipt of any immunostimulants at any time since birth.
• •* Receipt of any systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth (use of topical corticosteroids administered in limited areas of the body \[for example, eczema on knees or face or elbows\] is allowed).
• •* Immune deficiency disorder, or known HIV infection.
• •8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).
• •9. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• •10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
• •11. Taken any antipyretic medication in the previous 6 hours.
• •12. Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization).
• •13. Toddler's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
• •14. Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study.
• •15. Family members or household members of site research staff.
• •16. History or any illness/condition 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. Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).