Clinical Trial: Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

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

Official Title: Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD

Brief Summary:

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

Primary Objective:

To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.


Detailed Summary: This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination. [ Time Frame: Day 0 and Days 8 and 28 post-vaccination ]

Original Primary Outcome:

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


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: October 13, 2008
Date Started: March 2003
Date Completion:
Last Updated: January 21, 2014
Last Verified: January 2014