drugset / Trial / NCT00355121

Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

NCT00355121

Phase 2 Completed 882 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Timeline

Start
2006-10
Primary completion
2009-06
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine 0.5 ml Intramuscular
Subject IPOL Unknown 0.5 ml Intramuscular
Subject Menactra Vaccine 0.5 ml Intramuscular