GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for its recombinant RSV vaccine in China on ClinicalTrials.gov.
The vaccine, which received marketing approval in the U.S. in May 2023, will undergo a study that aims to complete its primary endpoint follow-up by March 2025. This trial is set to enroll 2,600 healthy participants aged 60 and older. The primary endpoint focuses on immunogenicity, specifically assessing neutralizing antibody titers for RSV-A and RSV-B, as well as the serum conversion rate, defined as a fourfold increase in neutralizing antibodies.- Flcube.com