drugset / Trial / NCT01270503

Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

NCT01270503

Phase 4 Completed 538 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Timeline

Start
2010-12
Primary completion
2013-12
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular