Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

Phase 2 Completed 47 enrolled Novartis Vaccines

Non-randomizedSingle-groupOpen-labelPrevention

Summary

To assess persistence of antibody titers 17-18 months after primary immunization with two 0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen, as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and Microneutralization (MN) test

Timeline

Start: 2007-10
Primary completion: 2007-12
Completion: 2008-06

Publications

Results Fragapane E, Gasparini R, Schioppa F, Laghi-Pasini F, Montomoli E, Banzhoff A. A heterologous MF59-adjuvanted H5N1 prepandemic influenza booster vaccine induces a robust, cross-reactive immune response in adults and the elderly. Clin Vaccine Immunol. 2010 Nov;17(11):1817-9. doi: 10.1128/CVI.00461-09. Epub 2010 Sep 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H5N1 Influenza Vaccine	Vaccine	7.5 ug	Intramuscular
Subject	H5N1 Influenza Vaccine	Vaccine	15 ug	Intramuscular

Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine

Summary

Timeline

Publications

Drugs

Indications