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Pharma & Biotech

GlaxoSmithKline hits the pause button on RSV vaccination trial

Enrolment was halted on the advice of an independent data monitoring committee

GlaxoSmithKline PLC (LSE:GSK) said it has paused a phase III clinical trial on safety grounds.

The recommendation to halt enrolment and vaccination in the GRACE study, which is evaluating GSK’s jab for respiratory syncytial virus (RSV) in pregnant women, was made by an independent data monitoring committee.

It said two other unnamed trials investigating its drug candidate in pregnant women had also been paused.

“Monitoring safety signals is an integral part of the clinical development process for potential new vaccines,” GSK said in a statement.

It added that the decision does not impact the ongoing AReSVi 006 phase III RSV study of people over the age of 60.

GSK said the trial remains on track with the initial data readout expected sometime in the first half.

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