0001654954-22-001820.txt : 20220218 0001654954-22-001820.hdr.sgml : 20220218 20220218060030 ACCESSION NUMBER: 0001654954-22-001820 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20220218 FILED AS OF DATE: 20220218 DATE AS OF CHANGE: 20220218 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GLAXOSMITHKLINE PLC CENTRAL INDEX KEY: 0001131399 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: X0 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-15170 FILM NUMBER: 22650772 BUSINESS ADDRESS: STREET 1: 980 GREAT WEST ROAD CITY: BRENTFORD MIDDLESEX STATE: X0 ZIP: TW8 9GS BUSINESS PHONE: 011442080475000 MAIL ADDRESS: STREET 1: 980 GREAT WEST ROAD CITY: BRENTFORD MIDDLESEX STATE: X0 ZIP: TW8 9GS 6-K 1 a0662c.htm GSK GIVES UPDATE ON RSV MATERNAL VACCINE CANDIDATE a0662c
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the month of February 2022
 
Commission File Number 001-15170
 
 
GlaxoSmithKline plc
(Translation of registrant's name into English)
 
 
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address of principal executive office)
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F . . . .X. . . . Form 40-F . . . . . . . .
 
 
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
 
 
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.
 
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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.
 
Registered in England & Wales:
No. 3888792

Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
 
 
 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.
 
GlaxoSmithKline plc
 
(Registrant)
 
 
Date: February 18, 2022
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GlaxoSmithKline plc