NCT00551031

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2,098 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. 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

• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)	0.1 mL, Intradermal (ID)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)	0.1 mL, Intradermal (ID)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)	0.5 mL, Intramuscular (IM)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine (High-dose)	0.5 mL, Intramuscular (IM)
BIOLOGICAL	Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)	0.5 mL, Intramuscular (IM)

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-06-01
• Completion: 2008-11-01
• First posted: 2007-10-30
• Last updated: 2016-05-16
• Results posted: 2011-11-24

Locations

29 sites across 1 country: United States