Vol.64 No.2 March 2016
Comparison of the immunogenicity and safety of ASP7374 (cell culture-derived influenza vaccine) with the immunogenicity and safety of an approved egg-derived trivalent inactivated influenza vaccine
1)Department of Infectious Diseases, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
2)Global Development, Astellas Pharma Inc.
3)Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital
Abstract
The immunogenicity (noninferiority) and safety of a single subcutaneous injection of a new influenza vaccine, ASP7374, were compared with an egg-derived trivalent inactivated influenza vaccine (ETIV) in this double-blinded clinical study. Adult healthy males and females (age range: 20-64 years) were assigned to a single injection of ASP7374 45 μg/strain group or the ETIV 15 μg/strain group.
The hemagglutination-inhibition (HI) antibody titer demonstrated that the immunogenicity of ASP7374 was not less than that of ETIV, satisfying the predefined noninferiority criteria. The neutralized antibody titer also suggested that the immunogenicity of ASP7374 was not less than that of ETIV. The frequency of adverse events with the ASP7374 injection was similar to that with the ETIV injection. Most of the local or systemic reactions in subjects who received the ASP7374 injection occurred within 2 days after administration, and they resolved within 8 days of onset.
In conclusion, the ASP7374 45 μg/strain subcutaneous injection demonstrated noninferiority of immunogenicity to an approved influenza vaccine and had a well-tolerated safety profile.
Key word
influenza, HA vaccine, phase III study, adult
Received
June 29, 2015
Accepted
November 17, 2015
Jpn. J. Chemother. 64 (2): 253-262, 2016
