drugset / Trial / NCT00631995

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

NCT00631995

Phase 1 Completed 360 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2008-04
Primary completion
2009-02
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject NeisVac-C Vaccine 0.5 ml Intramuscular
Subject TetraMen-T Vaccine 0.5 ml Intramuscular