NCT00391053

Immunogenicity of High-dose Inactivated, Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly

Phase III Lot Consistency, Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone® in Adults ≥ 65 Years of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,851 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need. Primary Objectives: Immunogenicity: * To demonstrate lot consistency of the Fluzone High Dose (Fluzone HD) manufacturing process through evaluation of the immune responses elicited by three different lots. * To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone® vaccine. Secondary Objectives: Immunogenicity: * To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone® vaccine. Safety: * To describe the safety profile of Fluzone HD, in terms of solicited -, unsolicited adverse and serious adverse events post-vaccination. * To describe clinical information on some additional defined criteria during the six months following vaccination.

Conditions

• Orthomyxoviridae Infection
• Influenza
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	High-Dose Inactivated, Split-Virion Influenza Vaccine	0.5 mL, IM
BIOLOGICAL	High-Dose Inactivated, Split-Virion Influenza Vaccine	0.5 mL, IM
BIOLOGICAL	High-Dose Inactivated, Split-Virion Influenza Vaccine	0.5 mL, IM
BIOLOGICAL	Inactivated, Split-Virion Influenza Vaccine	0.5 mL, IM

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-07-01
• Completion: 2008-02-01
• First posted: 2006-10-23
• Last updated: 2016-04-14
• Results posted: 2010-04-30

Locations

28 sites across 1 country: United States