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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.

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
NameTimeMethod
To provide information concerning the safety and immunogenicity after administration of TetraMenT30 days after each injection
Secondary Outcome Measures
NameTimeMethod

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