Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

Phase 3 Completed 3583 enrolled Alachua Government Services, Inc.

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.

Timeline

Start: 2008-08
Primary completion: 2009-07
Completion: 2010-10

Publications

van der Velden MV, Geisberger A, Dvorak T, Portsmouth D, Fritz R, Crowe BA, Herr W, Distler E, Wagner EM, Zeitlinger M, Sauermann R, Stephan C, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus H5N1 influenza vaccine in chronically ill and immunocompromised patients. Clin Vaccine Immunol. 2014 Jun;21(6):867-76. doi: 10.1128/CVI.00065-14. Epub 2014 Apr 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted	Vaccine	3.75 ug	Intramuscular
Subject	H5N1 Influenza Vaccine Whole virion, Vero cell-derived, Inactivated Influenza Vaccine, non-adjuvanted	Vaccine	7.5 ug	Intramuscular

Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups

Summary

Timeline

Publications

Drugs

Indications