drugset / Trial / NCT00389532

Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

NCT00389532

Phase 4 Completed 116 enrolled Sanofi Pasteur, a Sanofi Company
Non-randomizedParallel-groupOpen-labelPrevention

Summary

To submit remaining available sera to Center for Biologics Evaluation and Research (CBER) for further analysis by the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to support selection and recommendation of antigen strains for subsequent influenza vaccines.

Timeline

Start
2006-10
Primary completion
2008-04
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Influenza Virus Vaccine Vaccine

Indications