Clinical Trial: Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide

Brief Summary:

This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years.

Primary Objective:

To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.

Secondary Objective:

To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.


Detailed Summary:

Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.

There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.


Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28. [ Time Frame: Day 28 post-vaccination ]

Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.


Original Primary Outcome:

  • Immunogenicity: To provide information concerning the 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: 28 days post-vaccination and entire study duration ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sanofi

Dates:
Date Received: October 13, 2008
Date Started: January 2004
Date Completion:
Last Updated: January 21, 2014
Last Verified: January 2014