Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

Phase 2

Completed

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

• Registration Number: NCT00777790
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Description

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.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-04
• Study Completion: 2005-04
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Results First Submitted: 2008-12-02
• Results First Submitted QC: 2009-02-18
• Results First Posted: 2009-03-19
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menactra® Group	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Received Menactra® vaccine in Study MTA02
Menomune® Group	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Received Menomune® vaccine in Study MTA02
Control Group	Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Meningococcal vaccine-naïve Control Group.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.	Day 0 and 8 and 28 days post-vaccination	Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.