UK pharma major GSK (LSE: GSK) has announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase III trial.
AReSVi 006 is a Phase III trial investigating GSK’s respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above.
"Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022"The interim analysis was reviewed by an Independent Data Monitoring Committee, and the primary endpoint was exceeded with no unexpected safety concerns observed. As many as 25,000 participants were enrolled in the trial from 17 countries.
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