Vol.64 No.2 March 2016
A phase III clinical study on ASP7374 (recombinant influenza hemagglutinin vaccine) in elderly Japanese individuals
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 and safety of a single intramuscular injection (45 μg/strain) of a new influenza vaccine, ASP7374, was evaluated in this clinical study in male and female subjects aged ≥ 61 years.
The geometric mean hemagglutination-inhibition (HI) antibody titers had increased 28 days postvaccination from baseline for all strains.
In addition, the geometric mean neutralization antibody titers 28 days postvaccination had increased from baseline for all strains. ASP7374 vacination showed immunogenicity in aged subjects.
The proportions of subjects with adverse events and drug-related adverse events were 36.4% and 21.8%, respectively. No adverse events were reported in ≥ 10% subjects. Adverse events, such as malaise, pain, and nasopharyngitis, occurred in ≥ 5% subjects. The proportion of subjects with local and systemic reactions was 21.8%. Pain and malaise were the only events that occurred in ≥ 5% subjects. All of the local/systemic reactions occurred within the day following vaccination, and they resolved within 3 days from the occurrence. In conclusion, the ASP7374 intramuscular injection (45 μg/strain) met immunogenicity criteria and had a well-tolerated safety profile in the ≥ 61-year-old subjects.
Key word
influenza, HA vaccine, phase III study, intramuscular injection, elderly
Received
June 29, 2015
Accepted
November 17, 2015
Jpn. J. Chemother. 64 (2): 273-279, 2016
