GlaxoSmithKline (GSK) has announced that, further to the voluntary pause shared on 18th February, 2022, the company has decided to stop enrollment 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, the company said in a statement.
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, it further added.