Clinical Trial: Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomu
Brief Summary:
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.
Primary Objective:
To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.
Detailed Summary: All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome: Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups. [ Time Frame: Day 0 and 8 and 28 days post-vaccination ]
Original Primary Outcome:
- To provide information concerning immune response of Tetravalent meningococcal polysaccharide diphtheria conjugate vaccine after booster vaccination. [ Time Frame: 28 days post-vaccination ]
- To provide information concerning the safety after booster administration of Tetravalent meningococcal polysaccharide diphtheria conjugate vaccine. [ Time Frame: Entire study duration ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: October 21, 2008
Date Started: February 2004
Date Completion:
Last Updated: January 21, 2014
Last Verified: January 2014
