GSK Launches Pivotal Bridging Phase III Trial of RSV Vaccine in China with 4,400 Participants

▎Armstrong

On August 21, 2024, GSK registered the Phase III bridging clinical trial of its RSV vaccine in China on the Drug Clinical Trial Registration and Information Disclosure Platform.

This phase III clinical trial simultaneously enrolled subjects from China and overseas to compare immunogenicity.

This Phase III bridging clinical trial plans to enroll 4,400 participants, including 1,800 in China and 2,600 abroad.

The Phase III clinical bridging study was led by Director Xiaodong Sun of the Shanghai Center for Disease Control.

Summary

GSK and Pfizer's RSV vaccines were approved by the FDA in May last year, with combined first-year sales of $2.4 billion. Moderna's RSV mRNA vaccine was launched this year.Approved for marketing.In June this year, ACIP adjusted the recommended vaccination population to those over 75 years old.OrHigh-risk populations aged 60-74 (accounting for approximately 35-40%) are expected to see an acceleration in market penetration due to the increased recommendation level, changing from physician recommendation to recommendation upon meeting eligibility criteria.In addition, the current ACIP recommendation is for a single immunization, primarily due to the lack of clinical data supporting repeated immunizations.From the currently available RSV vaccines on the market, the decline in neutralizing antibodies is relatively rapid, and the protection period may not exceed two years. In the future, as data on repeated immunization becomes available, single-dose immunization may shift to repeated immunization.