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

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.

Timeline

Start

2007-10

Primary completion

2008-06

Completion

2008-11

Publications

• Tsang P, Gorse GJ, Strout CB, Sperling M, Greenberg DP, Ozol-Godfrey A, DiazGranados C, Landolfi V. Immunogenicity and safety of Fluzone((R)) intradermal and high-dose influenza vaccines in older adults >/=65 years of age: a randomized, controlled, phase II trial. Vaccine. 2014 May 1;32(21):2507-17. doi: 10.1016/j.vaccine.2013.09.074. Epub 2013 Oct 11.

Drugs

Indications