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

Phase 2

Terminated

• Conditions: Meningitis; Meningococcemia
• Interventions: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

• Registration Number: NCT00772629
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Description

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.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-13
• Study First Posted: 2008-10-15
• Results First Submitted: 2009-03-16
• Results First Submitted QC: 2009-03-16
• Results First Posted: 2009-04-27
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Subjects naïve to any meningococcal vaccination
Group 2	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Subjects who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135)

Primary Outcome Measures

Name	Time	Method
Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.	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.