GSK has unveiled positive data from its Phase III AReSVi-006 clinical trial of Arexvy, its RSV vaccine, which aims to prevent lower respiratory tract disease (LRTD) over three RSV seasons.
The trial, involving approximately 25,000 participants from 17 countries, focused on adults aged 60 years and older, including those at increased risk.
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The primary endpoint of the trial was to determine the vaccine’s efficacy against RSV-LRTD after one RSV season.
Following the initial season, 12,469 individuals from the vaccine group were re-randomised to receive either the RSV vaccine or a placebo.
The study then measured the vaccine’s efficacy over the subsequent two RSV seasons, with the results indicating a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD.
In the third RSV season alone, the vaccine’s efficacy reached 48% against RSV-LRTD.
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By GlobalDataThese findings also encompass efficacy across different RSV subtypes, in older adults between the ages of 70 and 79 years, and in those with certain pre-existing medical conditions.
The safety profile of the vaccine in the trial was found to be in line with prior data from the Phase III programme.
Pain at the injection site, fatigue, myalgia, headache and arthralgia within the first four days post-vaccination were reported to be the most common adverse events in the trial.
GSK chief scientific officer Tony Wood said: “We are excited by these new data, which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV disease over three seasons to benefit public health.
“This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer-term follow-up to help recommending bodies determine future revaccination schedules.”
In September this year, the company reported positive interim results from its Phase II trial of its mRNA-based multivalent influenza vaccine candidate, GSK4382276A.
