Vol.64 No.2 March 2016
A phase III comparison study on ASP7374 (cell culture-derived influenza vaccine) and an approved egg-derived trivalent inactivated influenza vaccine in elderly subjects
1)Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, 3-1-1 Takeoka, Kiyose, Tokyo, Japan
2)Global Development, Astellas Pharma Inc.
3)Department of Infectious Diseases, Keio University School of Medicine
Abstract
The immunogenicity (noninferiority) and safety of a single subcutaneous injection of a new influenza vaccine, ASP7374, in elderly subjects was compared with an egg-derived trivalent inactivated influenza vaccine (ETIV) in this double-blinded clinical study. Elderly healthy males and females (age: ≥ 65 years) were assigned to the ASP7374 45 μg/strain group or ETIV 15 μg/strain group with a single injection given in both groups.
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 in whom the ASP7374 injection was administered occurred within 3 days after administration, and they resolved within 14 days.
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 in elderly subjects.
Key word
influenza, HA vaccine, phase III study, elderly
Received
June 29, 2015
Accepted
January 5, 2016
Jpn. J. Chemother. 64 (2): 263-272, 2016
