drugset
drugset / Trial / NCT00389857

Trial to Collect Safety Data and Sera for Immunogenicity Testing

NCT00389857 ↗

Phase 4 Completed 31 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

To provide Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).

Timeline

Start
2006-10
Primary completion
2007-09
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine 0.25 ml Intramuscular

Indications

influenza