Initiation of a Phase 3 Additional Dose Clinical Trial in Japanese Subjects of the Monovalent Vaccine for the XBB1.5 Strain, S-268023

OSAKA, Japan, December 18, 2023 - Shionogi & Co., Ltd.  (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that it has initiated a Phase 3 additional dose clinical trial in Japanese subjects of the monovalent vaccine for the XBB1.5 strain (code No. S-268023), against COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection.


This clinical trial (jRCT2031230503) is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of S-268023 or COMINATY RTU (Monovalent: XBB.1.5) in 600 adults who have received the approved COVID-19 vaccine two or more times, will be compared.


Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only conducting research and development of novel therapeutics, but we are also working towards total care, through building awareness, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as treating the infection itself. By obtaining manufacturing and sales approval for S-268023, along with S-268019, which is currently undergoing manufacturing and sales approval application in Japan, we will establish a platform as the first domestically produced recombinant protein vaccine. This achievement will contribute to the provision of domestically produced vaccines in the future.


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