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Clinical Trial 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.


Clinical Trial Description

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


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00643916
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date December 2004
Completion date October 2007

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