Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Phase of Trial: Phase III
Latest Information Update: 13 Sep 2017
At a glance
- Drugs GSK 1437173A (Primary)
- Indications Herpes zoster; Varicella zoster virus infections
- Focus Registrational; Therapeutic Use
- Acronyms ZOE-50; ZOSTER-006
- Sponsors GlaxoSmithKline
- 13 Sep 2017 According to a GlaxoSmithKline media release, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix, for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA.
- 21 Jun 2017 According to a GlaxoSmithKline media release, data from this study were presented at the US Centers for Disease Control and Preventions Advisory Committee on Immunization Practices (ACIP) meeting.
- 18 Apr 2017 According to a GlaxoSmithKline media release, the compnay has submitted a New Drug Application (NDA) in Japan seeking approval for the candidate shingles vaccine, Shingrix, for the prevention of herpes zoster (shingles) in people aged 50 years or over. The application included data from ZOE-50 and ZOE-70 studies.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History