Clinical Trial: Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

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

Official Title: Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Ch

Brief Summary:

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.


Detailed Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Geometric Mean of Antibody Titers (GMTs) as Measured by Serum Bactericidal Assay (SBA) at Baseline (Day 0) and Day 28 Post-vaccination. [ Time Frame: Day 0 (before) and 28 days post-vaccination ]

Original Primary Outcome:

  • Immunogenicity: To provide information concerning the immune response of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post-vaccination ]
  • Safety: To provide information concerning the safety after administration of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post-vaccination ]


Current Secondary Outcome: Participants With a ≥ 4-Fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Baseline to Day 28 Post-vaccination. [ Time Frame: 28 days post-vaccination ]

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: October 13, 2008
Date Started: August 2003
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016