REG - GlaxoSmithKline PLC - GSK gives update on RSV maternal vaccine candidate

GSKAnnouncement

18/02/2022 07:15

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RNS Number : 0652C  GlaxoSmithKline PLC  18 February 2022

Issued: 18 February 2022, London UK

 

GSK provides update on phase III RSV maternal vaccine candidate programme

 

 

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.

 

About GSK

GSK is a science-led global healthcare company. For further information please
visit www.gsk.com/about-us (https://www.gsk.com/en-gb/about-us/) .

 

 

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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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