Clinical Trial: Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine

Brief Summary: Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Detailed Summary: The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.
Sponsor: Novartis Vaccines

Current Primary Outcome: Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA. [ Time Frame: Overall study period ]

Original Primary Outcome:

Current Secondary Outcome: Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA. [ Time Frame: Overall study period ]

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: April 3, 2006
Date Started: October 2005
Date Completion:
Last Updated: February 6, 2012
Last Verified: February 2012