Drugs / Shingrix
Shingrix
also known as
GSK 1437173A · RZV · HZ/su · Recombinant zoster vaccine · 1437173A · Herpes Zoster Vaccine · Herpes Zoster vaccine (GSK1437173A) · Herpes Zoster Vaccine 1437173A · +5 more
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed herpes zoster 5 milestones | |||||
| Filed | EU (EMA) | Shingrix | herpes zoster | 2025-01-27 | “the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix” gsk.com ↗ |
| Filed | US (FDA) | Shingrix | herpes zoster | 2025-01-10 | “the US Food and Drug Administration (FDA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix” gsk.com ↗ |
| Filed | China (NMPA) | Shingrix | herpes zoster | 2024-02-06 | “the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix” gsk.com ↗ |
| Filed | Japan (PMDA) | Shingrix | herpes zoster | 2022-06-28 | “today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Shingrix” gsk.com ↗ |
| Filed | Japan (PMDA) | Shingrix | herpes zoster | 2017-04-18 | “submitted a New Drug Application in Japan seeking approval for the candidate shingles vaccine, Shingrix, for the prevention of herpes zoster” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Shingrix | — | 2018-03-21 | europa.eu ↗ |
Trials 51
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT04523246 | Sep 2020 → Dec 2021 | COVID-19, herpes zoster | University of Oklahoma | Completed | No outcome recorded |
| Phase 0 | NCT03953196 | Apr → Dec 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 0 | NCT03771157 | Feb 2019 → Sep 2020 | B-cell chronic lymphocytic leukemia, Waldenstrom macroglobulinemia | University of Rochester | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT07285265 | May → Nov 2025 overdue | varicella zoster infection | Suzhou Abogen Biosciences Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04210752 | Feb → Dec 2020 | herpes zoster | EyeGene Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01086449 | Mar → Jun 2010 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06569823 | Jun 2024 → Nov 2027 expected | herpes zoster | Dynavax Technologies Corporation | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05580458 | Mar 2023 → Feb 2027 expected | herpes zoster | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07443709 | Apr → Dec 2026 expected | herpes zoster | Oriol Manuel | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07311148 | Oct 2025 → Jan 2026 overdue | herpes zoster | Guangzhou Patronus Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05554068 | Mar 2023 → Mar 2025 overdue | herpes zoster | Loyola University | Recruiting | No outcome recorded |
| Phase 2 | NCT05082688 | Sep 2021 → May 2023 | herpes zoster, influenza | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT04047979 | Nov 2019 → Apr 2023 | chickenpox, herpes zoster | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT03894969 | Apr 2019 → Aug 2020 | respiratory system disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT03604406 | May 2014 → Jun 2024 | herpes zoster, rheumatoid arthritis | Kevin Winthrop | Completed | No outcome recorded |
| Phase 2 | NCT01165203 | Sep 2010 → Jul 2012 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00920218 | Jul 2009 → Apr 2011 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00802464 | Jan 2009 → Jul 2010 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 324 trials · 11 met primary | ||||||
| Phase 3 | NCT06001606 | May 2023 → Apr 2025 | herpes zoster, systemic lupus erythematosus | Seoul National University Hospital | Unknown | Met primary |
| Phase 3 | NCT04128189 | Mar 2023 → Jun 2029 expected | chronic renal failure syndrome, herpes zoster | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 3 | NCT04176939 | Dec 2019 → Aug 2022 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04091451 | Sep 2019 → Feb 2024 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT03685682 | May 2018 → Sep 2019 | varicella zoster infection | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT03439657 | Apr 2018 → May 2019 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02979639 | Jan → Apr 2017 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02723773 | Apr 2016 → Jun 2023 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02735915 | Apr 2016 → Aug 2017 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02690207 | Mar 2016 → Mar 2019 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02581410 | Dec 2015 → Aug 2016 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02075515 | Aug 2014 → Apr 2015 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02058589 | Mar 2014 → May 2016 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02045836 | Mar 2014 → Jul 2015 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02052596 | Feb 2014 → Jun 2015 | herpes zoster | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01954251 | Oct 2013 → Jun 2014 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01777321 | Jun → Oct 2013 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01827839 | Jun 2013 → Feb 2014 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01751165 | Mar 2013 → May 2014 | herpes zoster | GlaxoSmithKline | Completed | Mixed |
| Phase 3 | NCT01798056 | Mar 2013 → Jun 2015 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01767467 | Mar 2013 → Jan 2016 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01610414 | Jul 2012 → Nov 2016 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01165229 | Aug 2010 → Jul 2015 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01165177 | Aug 2010 → May 2014 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 48 trials · 1 met primary | ||||||
| Phase 4 | NCT07485283 | Apr 2026 → Apr 2029 expected | cardiovascular disorder, dementia | Tor Biering-Sørensen | Recruiting | No outcome recorded |
| Phase 4 | NCT06763783 | Dec 2024 → Dec 2029 expected | juvenile chronic polyarthritis, polymyalgia rheumatica, psoriatic arthritis, scleroderma +3 | Region Skane | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05898464 | Jun 2023 → Feb 2026 | — | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 4 | NCT04403139 | Apr 2022 → Dec 2026 expected | varicella zoster infection | University of Washington | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04869982 | May 2021 → Apr 2023 | herpes zoster | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT03591770 | Jul 2019 → Jul 2024 | inflammatory bowel disease | Boston Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03493776 | Apr 2018 → Sep 2019 | varicella zoster infection | Deepali Kumar | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06262776 | Mar 2024 → Dec 2026 expected | immunodeficiency disease | Central Adelaide Local Health Network Incorporated | Recruiting | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 1 | NCT06874842 Comparator | Mar 2025 → Feb 2026 overdue | herpes zoster | Guangzhou Patronus Biotech Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06409494 Comparator | Jul 2024 → Jul 2025 overdue | herpes zoster | EuBiologics Co.,Ltd | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06375512 Comparator | Jul 2024 → Feb 2026 | herpes zoster | Shenzhen Shenxin Biotechnology Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06335849 Comparator | Mar 2024 → Sep 2025 overdue | herpes zoster | Guangzhou Patronus Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05991427 Comparator | Nov 2023 → Nov 2024 | herpes zoster | CanSino Biologics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05871541 Comparator | May 2023 → Mar 2024 | herpes zoster | Immorna Biotherapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06137755 Comparator | Mar 2023 → Mar 2025 overdue | herpes zoster | CHA Vaccine Institute Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05769049 Comparator | Feb → Dec 2023 | herpes zoster | Jiangsu Rec-Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05636436 Comparator | Dec 2022 → Dec 2024 overdue | herpes zoster | MAXVAX Biotechnology Limited Liability Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05245838 Comparator | Jan → Oct 2022 | herpes zoster | Dynavax Technologies Corporation | Completed | No outcome recorded |
| Phase 1/2 | NCT07400003 Comparator | Jan → May 2026 overdue | herpes zoster | Sinovac Biotech Co., Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06932523 Comparator | Apr 2025 → Jun 2026 overdue | herpes zoster | Shanghai Institute Of Biological Products | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06801509 Comparator | Feb → Nov 2025 overdue | herpes zoster | Sinocelltech Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05703607 Comparator | Jan 2023 → Sep 2025 | herpes zoster | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT05701800 Comparator | Jan 2023 → Jun 2026 overdue | herpes zoster | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07205796 Comparator | May 2026 → Dec 2027 expected | herpes zoster | Shenzhen Shenxin Biotechnology Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07481604 Comparator | Apr 2026 → Jan 2027 expected | herpes zoster | CHA Vaccine Institute Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06581575 Comparator | Oct 2024 → Aug 2026 overdue | herpes zoster | Immorna Biotherapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05856084 Comparator | May 2023 → Dec 2024 overdue | herpes zoster | MAXVAX Biotechnology Limited Liability Company | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05304351 Comparator | Feb 2022 → Jun 2026 overdue | herpes zoster | Curevo Inc | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00434577 Comparator | Feb → Oct 2007 | herpes zoster | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT04748939 Comparator | Sep 2026 | herpes zoster | Tuen Mun Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT05550194 Background | Mar 2023 → Aug 2027 expected | achalasia | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05007041 Comparator | Sep 2021 → Mar 2023 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT04169009 Comparator | Jul 2020 → Mar 2023 | herpes zoster | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT03798691 Comparator | May 2019 → Oct 2023 | Crohn disease, herpes zoster, ulcerative colitis | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT03886038 Comparator | Mar 2019 → Feb 2022 | rheumatoid arthritis | Region Skane | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| 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). |
| 2026-01-07 | GlaxoSmithKline | Regulatory GSK’s Shingrix (Recombinant Zoster Vaccine) prefilled syringe presentation approved by the European Commission gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Commission’s (EC) approval of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) in a prefilled syringe. |
| 2025-10-21 | GlaxoSmithKline | Regulatory GSK’s Shingrix new prefilled syringe presentation receives positive CHMP opinion gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to support the approval of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) in a prefilled syringe. |
| 2025-10-14 | GlaxoSmithKline | Regulatory GSK’s Shingrix approved in China for prevention of shingles in adults aged 18 and over who are at increased risk due to immunodeficiency or immunosuppression gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration (NMPA) has approved Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged 18 years and over who are at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. |
| 2025-07-29 | GlaxoSmithKline | Results GSK highlights new findings on Dementia and Alzheimer’s Disease at AAIC 2025, building on leadership in immunology and inflammation gsk.com ↗
Individuals vaccinated with two doses of RZV had a statistically significant reduction of dementia risk (33% lower risk of all- cause dementia compared to unvaccinated individuals who attended at least one preventive care visit). |
| 2025-07-17 | GlaxoSmithKline | Regulatory US FDA approves GSK’s Shingrix in a prefilled syringe presentation gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). |
| 2025-01-27 | GlaxoSmithKline | Regulatory GSK’s Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the prevention of shingles (herpes zoster). |
| 2025-01-10 | GlaxoSmithKline | Regulatory GSK’s Shingrix new prefilled syringe presentation accepted for review by US FDA gsk.com ↗ |
| 2024-10-10 | ViiV Healthcare | Results GSK AND ViiV HEALTHCARE TO SHOWCASE ADVANCES ACROSS INDUSTRY-LEADING INFECTIOUS DISEASE PORTFOLIO AT IDWEEK 2024 viivhealthcare.com ↗
Characterization of Herpes Zoster Cases and Sustained High Vaccine Efficacy Against Herpes Zoster Complications in Individuals Vaccinated with Recombinant Zoster Vaccine During A Long-Term Follow-Up Study |
| 2024-07-30 | GlaxoSmithKline | Results GSK presents new data at the Alzheimer's Association International Conference 2024 gsk.com ↗
Retrospective study observed statistically significant association between Shingrix vaccination and reduction of dementia risk, compared to Zostavax and Pneumovax 23, with further studies planned |
| 2024-04-17 | GlaxoSmithKline | Results New long-term data show Shingrix continues to provide high protection against shingles in adults aged 50 and over for more than a decade gsk.com ↗
The final trial data demonstrate that RZV maintains efficacy against shingles for more than a decade in adults over 50. |
| 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 ↗ |
| 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. |
| 2023-06-26 | GlaxoSmithKline | Regulatory Japan’s Ministry of Health, Labour and Welfare approves Shingrix for the prevention of shingles in at-risk adults aged 18 and over gsk.com ↗ |
| 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. |
| 2022-10-12 | GlaxoSmithKline | Results GSK to present updates on its industry-leading infectious disease portfolio at IDWeek 2022 gsk.com ↗
Reinforcing the strength of GSK’s portfolio of vaccines, data from an extension study exploring the efficacy and safety of Shingrix over ten years will also be shared for the first time, providing further evidence on the duration of protection for adults aged 50 years and over. |
| 2022-06-28 | GlaxoSmithKline | Regulatory Japan’s Ministry of Health, Labour and Welfare accepts Shingrix regulatory submission to prevent shingles in at-risk adults aged 18 years and older gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are at increased risk. |
| 2021-10-20 | GlaxoSmithKline | Regulatory US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes unanimously to recommend Shingrix for immunocompromised adults aged 19 and up gsk.com ↗
GlaxoSmithKline plc today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend two doses of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) and its complications in adults 19 years of age and older who are or will be immunodeficient or immunosuppressed due to disease or therapy. |
| 2021-07-26 | GlaxoSmithKline | Regulatory Shingrix approved in the US for prevention of shingles in immunocompromised adults gsk.com ↗
The approval for this new population expands the number of people who can be protected against shingles by Shingrix. |
| 2019-05-23 | GlaxoSmithKline | Regulatory GSK announces approval of Shingrix in China for prevention of shingles in adults aged 50 and over gsk.com ↗
Issued: London, UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. |
| 2018-03-23 | GlaxoSmithKline | Regulatory Shingrix approved in Europe and Japan 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 Commission has approved Shingrix for the prevention of shingles (herpes zoster) and post-herpetic neuralgia (PHN) in adults aged 50 years or older. |
| 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 ↗ |
| 2017-12-06 | GlaxoSmithKline | Results New data supports the safety and efficacy of GSK’s Shingrix in preventing shingles in autologous haematopoietic stem cell transplant patients gsk.com ↗
The ZOE-HSCT study succeeded in its primary objective by demonstrating an efficacy of 68.17% [95%CI: 55.56 - 77.53] against shingles in subjects above 18 years of age after receiving an autologous haematopoietic stem cell transplant. |
| 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 preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications. |
| 2017-10-25 | Agenus Inc. | Regulatory Shingrix with QS-21 Stimulon® Receives Positive Recommendation from CDC's Advisory Committee on Immunization Practices as Preferred Vaccine for Prevention of Shingles agenusbio.com ↗
Herpes Zoster subunit vaccine (Shingrix) is preferred over Zoster Vaccine Live (Zostavax) for the prevention of herpes zoster and related complications. |
| 2017-10-23 | GlaxoSmithKline | Regulatory Shingrix approved in the US for prevention of shingles in adults aged 50 and over gsk.com ↗
Issued: London UK GlaxoSmithKline plc [LSE/NYSE: GSK] today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. |
| 2017-10-20 | Agenus Inc. | Regulatory FDA Approves GSK's Shingles Vaccine with Agenus' QS-21 Stimulon® Adjuvant agenusbio.com ↗
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline's (GSK) herpes zoster vaccine, SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21 Stimulon®. |
| 2017-10-13 | GlaxoSmithKline | Regulatory GSK announces first approval of Shingrix in Canada gsk.com ↗
Issued: London UK GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Shingrix has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older. |
| 2017-09-13 | GlaxoSmithKline | Regulatory FDA Advisory Committee votes unanimously for Shingrix (HZ/su) in the US for prevention of herpes zoster (shingles) in adults ages 50 and over gsk.com ↗ |
| 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 ↗ |
| 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 ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration (FDA), seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over. |
| 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 ↗
A pooled analysis of data from both trials showed the vaccine demonstrated 91% efficacy against shingles (95% confidence interval: 86-95%) in adults aged 70 years and older compared to placebo1. |
| 2015-10-27 | GlaxoSmithKline | Results GSK’s candidate shingles vaccine demonstrates 90% efficacy against shingles in people 70 years of age and over gsk.com ↗
Shingrix was demonstrated to be 89% (95% confidence interval: 69– 97) efficacious in preventing PHN in people aged 70 years and over and 91% (95% confidence interval: 76– 98) efficacious in people aged 50 years and over. |
| 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 ↗
Agenus Inc. (NASDAQ:AGEN), an immunology company discovering and developing innovative treatments for cancer and other diseases, announced today that GlaxoSmithKline’s plc (LSE/NYSE:GSK) second pivotal Phase III efficacy study of its shingles vaccine candidate containing Agenus’ QS-21 Stimulon® adjuvant demonstrated 90% overall efficacy against shingles compared to placebo. |
All press releases naming this drug 37 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 84 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Shingrix | “A double-blind randomized controlled trial on the safety and immunogenicity of the recombinant subunit herpes zoster vaccine, Shingrix, in patients with rheumatic diseases...” NCT04748939 ↗52“A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was...” NCT03685682 ↗ “Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix.” NCT03439657 ↗ “A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older.” NCT03493776 ↗ “Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).” NCT07311148 ↗ “Participants aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).” NCT05856084 ↗ “Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).” NCT06874842 ↗ “Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).” NCT05636436 ↗ “Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years” NCT04869982 ↗ “Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart” NCT05898464 ↗ “Varicella Zoster Vaccine (Shingrix)” NCT03604406 ↗ |
| Known as | 1437173A | “the GSK Biologicals' HZ vaccine 1437173A administered on either a 0,2-; 0,6- or 0,12-month schedule” NCT01751165 ↗ |
| Known as | GSK 1437173A | “Male or female subjects, 18 years of age or older at the time of the first vaccination, received 3 doses of GSK 1437173A formulation 1 (F1) vaccine, administered...” NCT00920218 ↗36“The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when...” NCT00920218 ↗ “The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered...” NCT01777321 ↗ “Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle...” NCT02058589 ↗ “Subjects received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.” NCT01610414 ↗ “Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2.” NCT02045836 ↗ “Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies” NCT01767467 ↗ “Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older” NCT02052596 ↗ “Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years” NCT04869982 ↗ “Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)” NCT03894969 ↗ “Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age” NCT02581410 ↗ |
| Known as | Herpes Zoster Vaccine | “Herpes Zoster Vaccine GSK1437173A” NCT02723773 ↗ |
| Known as | Herpes Zoster vaccine (GSK1437173A) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01827839 ↗ |
| Known as | Herpes Zoster Vaccine 1437173A | “Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A” NCT00920218 ↗ |
| Known as | HZ/su | “The impact of alternate routes of vaccine administration, subcutaneous (SC) or intramuscular (IM), on the safety and immunogenicity of herpes zoster subunit candidate vaccine...” PMID 27936344 ↗ Dec 20163“assessed whether (re)vaccination with the adjuvanted HZ subunit vaccine candidate (HZ/su) induced comparable immune responses in previous ZVL recipients and ZVL-naive...” PMID 29029122 ↗ Dec 2017 “2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01B Adjuvant System)” PMID 29174683 ↗ Nov 2017 “Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)” NCT04091451 ↗ |
| Known as | HZ/su vaccine | “HZ/su vaccine (GSK1437173A)” NCT04176939 ↗ |
| Known as | Recombinant Herpes Zoster Vaccine | “Recombinant Herpes Zoster Vaccine (Shingrix)” NCT07485283 ↗ |
| Known as | Recombinant zoster vaccine | “Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years” NCT04869982 ↗2“The recombinant zoster vaccine (RZV, Shingrix®) has shown high efficacy in immunocompetent adults.” NCT07443709 ↗ “Two doses of recombinant zoster vaccine(Shingrix®), 2 months apart” NCT05898464 ↗ |
| Known as | Recombinant zoster vaccine adjuvanted | “Recombinant zoster vaccine adjuvanted (SHINGRIX)” NCT06262776 ↗ |
| Known as | RZV | “The recombinant subunit herpes zoster vaccine (RZV) is indicated for VZV-seropositive persons to prevent shingles but could potentially also protect VZV-seronegative persons...” PMID 33528118 ↗ Oct 20214“the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA)” PMID 33606577 ↗ Feb 2021 “We evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) in previous ZVL recipients.” PMID 32103273 ↗ Oct 2021 “The recombinant zoster vaccine (RZV, Shingrix®) has shown high efficacy in immunocompetent adults.” NCT07443709 ↗ |
| Known as | SRX | “The study plans to learn more about how the shingles vaccine, Shingrix (SRX), successfully prevents shingles in older people.” NCT04169009 ↗ |
| Known as | Zoster Vaccine Recombinant, Adjuvanted | “Zoster Vaccine Recombinant, Adjuvanted (Shingrix)” NCT05991427 ↗ |
| Modality | Vaccine | “GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles).” NCT00434577 ↗ |
| Route | Intramuscular | “administered intramuscularly” NCT00802464 ↗ |