LONDON (dpa-AFX) - GSK plc (GSK.L) Thursday said late-stage study of its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above met its primary goal.
Results from Phase 3 study of the company's investigational vaccine RSVPreF3 OA showed 94.1% reduction in severe RSV lower respiratory tract disease (RSV-LRTD) with overall efficacy of 82.6%.
In the Phase 3 study dubbed AReSVi-006, about 25,000 participants were enrolled from 17 countries to show the efficacy of a single dose of RSVPreF3 OA.
In participants with pre-existing comorbidities, vaccine efficacy was 94.6% with 93.8% efficacy observed in adults aged 70-79 years, the company said.
Further, robust neutralizing antibody response generated against both RSV-A and RSV-B subtypes was also observed.
Data from the study is expected to be presented at IDWeek 2022 to be held between October 19 and 23.
The company plans to submit application for regulatory approval in the second half of 2022.
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