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GSK Announces Positive Phase III Data For RSV Vaccine Candidate For Older Adults

GSK plc. (GSK,GSK.L) announced a positive pivotal phase III data for its respiratory syncytial virus vaccine candidate for adults aged 60 years and above.

Respiratory syncytial virus or RSV is a common contagious virus affecting the lungs and breathing passages.

The company noted that the primary endpoint was exceeded with no unexpected safety concerns observed in the 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 vaccine candidate for the older adults.

The company said data suggested RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection. The company plans to engage with regulators immediately and anticipates regulatory submissions in the second half of 2022.

According to the company, the AReSVi 006 trial will continue to evaluate both an annual revaccination schedule and longer-term protection over multiple seasons following one dose of the RSV older adult vaccine candidate.

GSK's respiratory syncytial virus older adults vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01 adjuvant.

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