drugset / Trial / NCT00643916

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

NCT00643916

Phase 2 Completed 378 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2004-12
Primary completion
2006-03
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular
Comparator Menomune® Vaccine 0.5 ml Subcutaneous