12 Mar 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Astellas Pharma and UMN Pharma have highlighted that the summary results for phase III clinical trial showed non-inferiority of the recombinant seasonal influenza HA vaccine ASP7374 when compared with egg-derived vaccine in terms of immunogenicity.
No major safety problem have been observed in the study. The clinical study enrolled 1,060 elderly volunteers to compare the immunogenicity and safety of ASP7374 with approved egg-derived trivalent inactivated vaccine and to prove non-inferiority of ASP7374 to the egg-derived vaccine.
The recombinant seasonal influenza HA vaccine ASP7374, containing three different strains of antigens, has been produced by a cell-culture manufacturing method that employs the Baculovirus Expression Vector System.
This is a next-generation technology platform for manufacturing biopharma products. Protein Sciences Corporation obtained approval for this vaccine from the US FDA in January 2013.