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 Using Four Different Vaccination Schedules

Summary

The present study will evaluate the immunogenicity, 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 Subjects.

Timeline

Start

2008-11

Primary completion

2009-06

Completion

2009-06

Outcome

Mixed primary results

paper The vaccine met 2 of the 3 European licensure criteria, with seroconversion rates of 69% and 65% PMID 21316535 ↗

paper The CHMP criterion for seroprotection was achieved when the 2 doses of vaccine were separated by 2 (76%), 3 (72%), and 6 (79%) weeks PMID 21316535 ↗

Publications

• Results Beran J, Abdel-Messih IA, Raupachova J, Hobzova L, Fragapane E. A phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses. Clin Ther. 2010 Dec;32(13):2186-97. doi: 10.1016/S0149-2918(11)00024-5.

Drugs

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

Indications

No indication recorded.