Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

Phase 2

Completed

• Conditions: Meningococcemia; Neisseria Meningitidis; Meningitis
• Interventions: Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

• Registration Number: NCT00772070
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier.

Primary Objective:

To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.

Detailed Description

This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-08
• Study Completion: 2004-05
• Study First Submitted: 2008-10-13
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Results First Submitted: 2009-03-26
• Results First Submitted QC: 2009-03-26
• Results First Posted: 2009-05-14
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previously received TetraMenD	A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)	Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Meningococcal vaccine-naїve	A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)	Participants have never received a Meningococcal vaccine in the past.

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.	Day 0 and Days 8 and 28 post-vaccination