Drugs / HZ/su vaccine
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05371080 | Aug 2022 → Aug 2027 expected | herpes zoster | GlaxoSmithKline | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | GlaxoSmithKline | Regulatory GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved in Japan gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). |
| 2024-02-06 | GlaxoSmithKline | Regulatory GSK’s regulatory application for Shingrix for the prevention of shingles in at-risk adults aged 18 and over accepted for review by China National Medical Products Administration gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over at increased risk. |
| 2023-08-23 | GlaxoSmithKline | Results New Shingrix data demonstrate 100% vaccine efficacy in the prevention of shingles in adults aged 50 and over in China gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive results from the first-ever efficacy trial of Shingrix (Recombinant Zoster Vaccine or RZV) in China. |
| 2022-10-19 | GlaxoSmithKline | Results New data show Shingrix can provide at least 10 years of protection against shingles in adults aged 50 years and over gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced positive interim results from the ZOSTER-049 extension study showing that overall Shingrix (Zoster Vaccine Recombinant, Adjuvanted) can provide at least a decade of protection against shingles (herpes zoster) after initial vaccination. |
| 2018-01-26 | GlaxoSmithKline | Regulatory GSK’s Shingrix receives positive opinion from the CHMP in Europe for the prevention of shingles in adults aged 50 and over gsk.com ↗
Issued: London, UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN), the most common and often painful shingles-related complication, in adults aged 50 years or older. |
| 2017-10-25 | GlaxoSmithKline | Regulatory CDC’s Advisory Committee on Immunization Practices recommends Shingrix as the preferred vaccine for the prevention of shingles for adults aged 50 and up gsk.com ↗
Herpes Zoster subunit vaccine (Shingrix) is recommended for the prevention of herpes zoster and related complications for immunocompetent adults aged 50 years and older. |
| 2017-06-21 | GlaxoSmithKline | Results GSK presents positive results from Phase III revaccination study of its candidate shingles vaccine Shingrix at CDC’s Advisory Meeting gsk.com ↗
The study met its primary objective of demonstrating non-inferior immune response (i.e. antibody concentrations). |
| 2017-04-18 | GlaxoSmithKline | Regulatory GSK announces regulatory submission in Japan of its candidate vaccine for prevention of shingles gsk.com ↗
Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses. |
| 2016-10-27 | GlaxoSmithKline | Results GSK presents new data for shingles candidate vaccine at IDWeek scientific conference gsk.com ↗
The study concluded that in addition to helping prevent shingles, the candidate vaccine also reduced the severity of shingles in the few patients who developed the disease after vaccination. |
| 2016-10-24 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission of candidate vaccine for prevention of shingles gsk.com ↗ |
| 2016-09-14 | GlaxoSmithKline | Results GSK’s candidate shingles vaccine shows high efficacy against shingles and its complications in adults aged 70 years and over in phase III study published in NEJM gsk.com ↗
The study, from which headline results were reported in October 2015, showed that the two-dose candidate shingles vaccine had 90% efficacy (95% confidence interval: 84-94%) compared to placebo in people over 70 years old. |
| 2015-10-27 | Agenus Inc. | Results GSK’s candidate Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Demonstrates 90% Efficacy against Shingles and 89% Efficacy against Post-Herpetic Neuralgia in Adults aged 70 Years and Older agenusbio.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HZ/su vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05371080 ↗ |
| Known as | Herpes Zoster subunit vaccine | “Herpes Zoster subunit vaccine” NCT05371080 ↗ |
| Modality | Vaccine | “GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults.” NCT05371080 ↗ |