Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: MenC-CRM LIQ; MenC-CRM ROS; MenC-CRM EMV
Intervention description: One dose of MenC-CRM vaccine, liquid formulation; One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.; One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 992.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; vaccines; toddlers; prevention; Meningitis

Summary:

      The study was to evaluate the safety and and immune response of each of three lots of
      Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy
      Toddlers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy 12 - 23 (inclusive) month-old male or female toddlers.

          2. A parent/legal guardian was given written informed consent after the nature of the
             study has been explained.

          3. Available for both the visits scheduled in the study.

          4. In good health as determined by medical history, physical examination and clinical
             judgment of the investigator.

        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).