GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has voluntarily paused enrolment and vaccination in the GRACE phase III trial (NCT04605159), evaluating its potential respiratory syncytial virus (RSV) maternal vaccine candidate, as well as two other trials investigating this candidate in pregnant women (NCT04980391, NCT05229068).
This decision was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment. Monitoring safety signals is an integral part of the clinical development process for potential new vaccines.
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.
The Company will provide a further update on the RSV maternal vaccine candidate in due course.