Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

Phase 2

Completed

• Conditions: Meningitis; Meningococcemia
• Interventions: Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

• Registration Number: NCT00700713
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.

Objectives:

* To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.

* To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.

* To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Detailed Description

Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Disposition First Submitted: 2010-09-02
• Disposition First Submitted QC: 2010-09-02
• Disposition First Posted: 2010-09-08
• Status Verified: 2016-01
• Results First Submitted: 2016-01-16
• Results First Submitted QC: 2016-01-16
• Last Update Submitted: 2016-01-16
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One-Dose Menactra Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants received one dose of Menactra® in Study MTA26
Two-Dose Menactra Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants received two doses of Menactra® in Study MTA26
Menactra vaccine-naïve Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants had never received Menactra® vaccine.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®	Day 0 (pre-vaccination) and Day 30 post-vaccination	Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.