NCT00343681

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

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Orthomyxoviridae Infections

Interventions

Type	Name	Description
BIOLOGICAL	Inactivated influenza vaccine (split virion)	0.5 mL, Intramuscular

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2006-06-23
• Last updated: 2014-01-17

Locations

2 sites across 2 countries: Switzerland, United Kingdom