BRIEF—GSK to stop Phase III RSV maternal vaccine candidate enrollment

UK pharma major GlaxoSmithKline today announced that, further to the voluntary pause shared on  February 18, the company has decided to stop enrolment and vaccination in trials evaluating its potential respiratory syncytial virus (RSV) maternal vaccine candidate in pregnant women (NCT04605159, NCT04980391, NCT05229068).

Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed.

This decision does not impact the ongoing AReSVi 006 Phase III trial (NCT04886596) for RSV older adults (60 years and above).

This trial remains on track with an anticipated data readout in the first half of 2022.