Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers

Phase 1

Completed

• Conditions: Meningitis; Meningococcal Infection

• Registration Number: NCT00631995
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.

Primary Objectives: Safety and Immunogenicity:

To describe the safety and immunogenicity profiles of:

* A single dose of each formulation of TetraMen-T vaccine

* A single dose of NeisVac-C® vaccine.

Detailed Description

The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.

Study Timeline

• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-10
• Study Start: 2008-04
• Primary Completion: 2009-02
• Study Completion: 2009-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety and immunogenicity after administration of TetraMenT	30 days after each injection