GSK said that its respiratory syncytial virus (RSV) vaccine, Arexvy, has shown capability to help protect adults aged 50 to 59 at increased risk for RSV disease in a Phase 3 trial.
Arexvy has recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3).
GSK assessed the immune response and safety of Arexvy in older adults, including those at increased risk of RSV lower respiratory tract disease (LRTD) due to certain underlying medical issues.
Currently, the vaccine is approved in the US for active immunisation and for preventing RSV-LRTD in adults 60 years of age and older.
It is also authorised in Europe, Japan, and several other nations.
Arexvy met the trial’s primary endpoints by eliciting an immune response that was non-inferior to that observed in adults aged 60 and above.
The broader group of persons participating in the trial who were between the ages of 50 and 59 also achieved the co-primary endpoint.
Data on safety and reactogenicity matched those from the first Phase 3 programme, the British pharmaceutical firm said.
The most usual systemic adverse events were headache and weariness, both of which were temporary and mild in severity.
GSK chief scientific officer Tony Wood said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
“We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.”
The Phase 3 trial evaluating the RSV vaccine is a placebo-controlled, observer-blind, randomised, multi-country immunogenicity study. It featured around 1,520 participants across eight countries.
The trial is still going on to gather more immunological data at six and 12 months following vaccination delivery.
