Immunogenicity and Safety of Trivalent Inactivated Influenza Vaccine: A Randomized, Double-Blind, Multi-Center, Phase 3 Clinical Trial in a Vaccine-Limited Country

Abstract

Influenza vaccines are the primary method for controlling influenza and its complications. This study was conducted as a phase 3, randomized, double-blind, controlled, multicenter trial at seven university hospitals to evaluate the immunogenicity and safety of an inactivated, split, trivalent influenza vaccine (GC501, Green Cross Corporation, Yongin, Korea), which was newly manufactured in Korea in 2008. Between September 21 and 26, a total of 329 healthy subjects were recruited for the immunogenicity analysis, while 976 subjects were enrolled for the safety analysis. The GC501 vaccine met both FDA and EMEA criteria with >= 80% of subjects achieving post-vaccination titers >= 40 for all three subtypes, even in the elderly. The vaccine was well tolerated with only mild systemic and local adverse events. In summary, GC501 showed excellent immunogenicity and a good safety profile ill both young adults and the elderly. The licensure of GC501 might be an important basis in preparation for the future influenza pandemic.