GSK reports positive headline data from phase II seasonal influenza mRNA vaccine programme

GSK plc announced positive results from a Phase II trial (NCT06431607) for its mRNA seasonal influenza vaccine program. The trial evaluated different mRNA formulations in both younger and older adults to assess vaccine candidates that could enhance immune responses against influenza A and B strains compared to current vaccines.

In both age groups, the trial met its pre-defined success criteria. Interim data suggest the vaccine candidates have a favorable safety and reactogenicity profile across all mRNA formulations tested. These findings, building on a previous Phase II trial, show the mRNA platform generates strong antibody responses with an acceptable safety profile.

Following these results, GSK’s mRNA influenza vaccine will advance to late-stage clinical trials. GSK has also entered a licensing agreement with CureVac, gaining full control over developing influenza and COVID-19 vaccines. GSK is enhancing its mRNA technology through investments in AI/ML-based sequence optimization and nanoparticle design. The study involved 500 healthy adults aged 18 to 85, testing various doses against a licensed comparator vaccine.