Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

Phase 2

Completed

• Conditions: Meningitis; Meningococcal Infection
• Interventions: Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®); Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)

• Registration Number: NCT00643916
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

Detailed Description

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-03
• Study Completion: 2007-10
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Results First Submitted: 2009-09-24
• Results First Submitted QC: 2009-12-04
• Results First Posted: 2010-01-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccinated at Age 9 and 12 Months	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	Participants received Menactra® vaccine at 9 and 12 Months of age
Vaccinated at Age 9 and 15 Months	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	Participants received Menactra® vaccine at 9 and 15 Months of age
Vaccinated at Age 12 and 15 Months	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	Participants received Menactra® vaccine at Age 12 and 12 Months of age
Vaccinated at Age 15 Months	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	Participants received Menactra® vaccine at 15 Months of age
Vaccinated at Age 18 Months	Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)	Participants received Menactra® vaccine at 18 Months of age
Vaccinated at Age 3 Years to <6 Years	A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)	Participants received Menomune® vaccine at Age 3 years to \<6 years of age

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.	Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2