Clinical Trial: Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth I
Brief Summary: Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28.
Original Primary Outcome:
Current Secondary Outcome:
- Determination of antibody titers in naïve control subjects.
- Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age.
- Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age.
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: April 3, 2006
Date Started: June 2005
Date Completion:
Last Updated: October 25, 2006
Last Verified: October 2006
