GSK plc GSK announced new data from the AReSVi-006 phase 3 trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination.
The results show that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons.
A similar pattern of vaccine efficacy over two seasons was also observed in adults with underlying comorbidities and advancing age.
Related: GSK's Arexvy Gets the Green Light in Europe: First-Ever RSV Vaccine in Europe for Older Adults.
The trial also evaluated efficacy following an annual revaccination schedule as a confirmatory secondary endpoint. Cumulative efficacy over two seasons in participants who received a second dose of the vaccine was 67.1% (30 of 12,469 vs. 139 of 12,498), suggesting revaccination after 12 months does not appear to confer additional benefit for the overall population.
The clinical development program will continue to evaluate longer-term follow-up and the optimal timing for potential revaccination.
Safety and reactogenicity data were consistent with initial observations from the phase 3 program. The vaccine was generally well tolerated.
Price Action: GSK shares are up 0.78% at $34.88 during the premarket session on the last check Wednesday.
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