drugset / Trial / NCT00777257

Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

NCT00777257

Phase 4 Completed 1345 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedCrossoverQuadruple-blindPrevention

Summary

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Timeline

Start
2005-04
Primary completion
2007-03
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular
Subject tetanus toxoid Vaccine 0.5 ml Intramuscular