China-based Kexing Pharmaceutical (SHA: 688136) announced the start of a Phase III clinical trial in Chile to evaluate the safety and immunogenicity of its quadrivalent influenza virus split vaccine in individuals aged three and older. The vaccine received market approval in China in June 2020.
Study Details
The trial will enroll 1,600 volunteers across cities including Santiago and Puerto Montt. Half will receive one or two doses of Kexing’s vaccine, while the other half will receive the currently approved quadrivalent influenza vaccine in Chile. Safety will be assessed via adverse event data collected within 28 days post-vaccination, and immunogenicity will compare immune responses between the two vaccines.
Background and Significance
Kexing’s quadrivalent vaccine targets four influenza strains and aims to demonstrate comparable safety and efficacy to existing products. The study builds on the vaccine’s prior approval in China and seeks to validate its use in a broader population, potentially paving the way for global expansion.-Fineline Info & Tech
