Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects

Phase 2 Completed 343 enrolled Novartis Vaccines

Non-randomizedSingle-groupOpen-labelPrevention

Summary

The present study will evaluate the immunogenicity, safety and tolerability of two doses of monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult and Elderly Subjects.

Timeline

Start: 2008-12
Primary completion: 2009-07
Completion: 2009-11

Publications

Results Bihari I, Panczel G, Kovacs J, Beygo J, Fragapane E. Assessment of antigen-specific and cross-reactive antibody responses to an MF59-adjuvanted A/H5N1 prepandemic influenza vaccine in adult and elderly subjects. Clin Vaccine Immunol. 2012 Dec;19(12):1943-8. doi: 10.1128/CVI.00373-12. Epub 2012 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Monovalent inactivated influenza vaccine	Vaccine	7.5 ug	—

Indications

No indication recorded.