Astellas and UMN update on Ph III trials of flu vaccine ASP7374; debuts Irribow OD in Japan

Japanese drug major Astellas Pharma (TYO: 4503) and partner UMN Pharma (TYO: 4585) have announced promising summary results for two Phase III clinical trials of the recombinant seasonal influenza HA vaccine ASP7374 (former code: UMN-0502), that completed administration in October 2013.

One of these clinical trials enrolled 900 healthy volunteers aged from 20 to 64 years to compare the immunogenicity and safety of subcutaneously-administered ASP7374 with approved egg-derived trivalent inactivated vaccine and to prove non-inferiority of ASP7374 to the egg-derived vaccine. This showed non-inferiority of the recombinant seasonal influenza HA vaccine ASP7374 in comparison with the egg-based vaccine in terms of immunogenicity. No major safety problem was also observed in ASP7374 in this trial.

Another clinical trial enrolled 55 healthy volunteers aged 61 and over to evaluate the immunogenicity and safety of intramuscularly-administered ASP7374. This clinical trial showed favorable immunogenicity. No major safety problem was also observed in ASP7374 in this trial.