GSK has announced positive results from its clinical trial of AREXVY, a vaccine for respiratory syncytial virus (RSV) in older adults. The AReSVi-006 phase III trial found that the vaccine provided protection against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions. Safety and reactogenicity data were consistent with initial results from the program. The clinical development program will continue to evaluate longer term follow up and the optimal timing for revaccination.
The ongoing AReSVi-006 phase III trial evaluated GSK's adjuvanted RSV older adult vaccine in a randomized, placebo-controlled, observer-blind multi-country study to demonstrate efficacy over three years and following an annual revaccination schedule in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. Results showed that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons.
The ongoing clinical development program will continue to evaluate longer-term follow-up and the optimal timing for potential revaccination.