A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

Summary

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are: * To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency * To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

Timeline

Start

2006-07

Primary completion

2007-08

Completion

2007-08

Drugs

Indications