NCT00388583

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

Immunogenicity and Safety of The Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Ambulatory Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 817 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly. Primary Objective: To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®. Secondary Objectives: Immunogenicity: To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Conditions

• Orthomyxoviridae Infection
• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine	0.1 mL, Intradermal
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine	0.5 mL, Intramuscular

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-06-01
• Completion: 2008-09-01
• First posted: 2006-10-17
• Last updated: 2012-04-18
• Results posted: 2011-09-13

Locations

17 sites across 1 country: United States