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

2014-08-27 03:41:54 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Orthomyxoviridae Infection

Intervention

High-Dose Inactivated, Split-Virion Influenza Vaccine, High-Dose Inactivated, Split-Virion Influenza Vaccine, High-Dose Inactivated, Split-Virion Influenza Vaccine, Inactivated, Split-Virion Influenza Vaccine

Location

Mesa
Arizona
United States

Status

Completed

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:54-0400

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