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GSK RSV maternal vaccine candidate further update

RNS Number : 9414C

GlaxoSmithKline PLC

28 February 2022

Issued: 28 February 2022, London UK

GSK provides further update on phase III RSV maternal vaccine candidate programme

GlaxoSmithKline plc (LSE/NYSE: GSK) 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.

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020, GSK's 2021 Q4 Results and any impacts of the COVID-19 pandemic.

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