Drugs / Zostavax
Zostavax
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Zostavax | — | 2025-06-01 | europa.eu ↗ |
| Approved | EU (EMA) | Zostavax | — | 2006-05-19 | europa.eu ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT01506661 | Jan 2012 → Dec 2017 | rheumatoid arthritis, varicella zoster infection | Oklahoma Medical Research Foundation | Completed | No outcome recorded |
| Phase 1 | NCT01474720 | Nov 2011 → Jul 2012 | systemic lupus erythematosus | Oklahoma Medical Research Foundation | Completed | No outcome recorded |
| Phase 1 | NCT01385566 | Sep 2011 → May 2013 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 1 | NCT01262300 | Nov 2010 → Jan 2014 | herpes zoster, immune system disorder | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT01137669 | Sep 2010 → Feb 2015 | herpes zoster | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01213810 | Dec 2010 → Dec 2011 | herpes zoster | University of Zurich | Withdrawn | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03604406 | May 2014 → Jun 2024 | herpes zoster, rheumatoid arthritis | Kevin Winthrop | Completed | No outcome recorded |
| Phase 2 | NCT01573182 | Apr 2012 → May 2018 | herpes zoster | University of Sydney | Completed | No outcome recorded |
| Phase 2 | NCT00851786 | Apr 2009 → Sep 2011 | HIV infectious disease, herpes zoster | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02329457 | Dec 2014 → Sep 2019 | varicella zoster infection | The University of Hong Kong | Completed | Met primary |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT02519855 | Sep 2015 → Jan 2016 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01391546 | Jun 2011 → Oct 2012 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00561080 | Oct 2007 → Jun 2009 | herpes zoster | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00535730 | Jun 2007 → Feb 2008 | herpes zoster, pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 3 | NCT00231816 | Sep 2005 → Mar 2006 | herpes zoster | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT03016884 | Jan 2017 → Sep 2019 | herpes zoster | HaEmek Medical Center, Israel | Unknown | No outcome recorded |
| Phase 4 | NCT01911065 | Sep 2010 → Dec 2011 | herpes zoster | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00940940 | Oct 2009 → Aug 2013 | — | University of Alberta | Completed | No outcome recorded |
| Phase 4 | NCT00681031 | May → Jun 2008 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT03192319 | Jul 2017 → Aug 2018 | herpes zoster | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT02704572 | Mar 2016 → Aug 2017 | herpes zoster | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT02960399 | Dec 2015 → Dec 2017 | Bruton-type agammaglobulinemia, common variable immunodeficiency, immunodeficiency due to selective anti-polysaccharide antibody deficiency | University of South Florida | Terminated | No outcome recorded |
| — | NCT01331161 | Jul 2011 → Apr 2012 | herpes zoster | Emory University | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 1 | NCT02114333 Comparator | May 2014 → Mar 2016 | herpes zoster | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT03121638 Comparator | Nov 2012 → Feb 2013 | varicella zoster infection | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00886613 Comparator | Mar → Dec 2009 | herpes zoster | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 2/3 | NCT03116594 Comparator | Jan → Apr 2014 | herpes zoster | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03120364 Comparator | Sep → Dec 2015 | herpes zoster | SK Chemicals Co., Ltd. | Completed | Met primary |
| Phase 4 | NCT02477150 Comparator | Nov 2015 → Nov 2018 | systemic lupus erythematosus | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02444936 Comparator | May 2015 → May 2018 | herpes zoster | Louis Stokes VA Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02958345 Comparator | Jun 2013 → Jul 2015 | herpes zoster | Tulane University | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-02-24 | Merck Sharp & Dohme LLC | In First Phase 3 Trial, Merck’s Investigational Inactivated Varicella Zoster Virus Vaccine (V212) Reduced the Incidence of Confirmed Herpes Zoster Cases by an Estimated 64 Percent in Immunocompromised Subjects merck.com ↗ |
| 2013-10-23 | Merck Sharp & Dohme LLC | ZOSTAVAX® (Zoster Vaccine Live) Awarded Prix Galien USA 2013 Best Biotechnology Product merck.com ↗ |
| 2012-04-02 | Merck Sharp & Dohme LLC | Efficacy and Safety Data for ZOSTAVAX® (Zoster Vaccine Live), Merck’s Shingles Vaccine, in Adults Ages 50 to 59 Published in Clinical Infectious Diseases merck.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZOSTAVAX | “ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation.” NCT01137669 ↗ |
| Known as | Varicella Zoster Virus Vaccine | “Varicella Zoster Virus Vaccine (Zostavax)” NCT01262300 ↗ |
| Known as | ZOSTAVAX (Zoster Vaccine Live) | “ZOSTAVAX® (Zoster Vaccine Live)” NCT03016884 ↗ |
| Known as | Zoster Vaccine Live | “ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation.” NCT01137669 ↗3“ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous” NCT01385566 ↗ “ZOSTAVAX® (Zoster Vaccine Live)” NCT00851786 ↗ “Zoster vaccine live” NCT00561080 ↗ |
| Known as | Zoster Vaccine, Live, (Oka-Merck) | “Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™” NCT00535730 ↗ |
| Action | Activate | “Vaccination with an attenuated form of the VZV activates specific T-cell production avoiding viral reactivation.” PMID 37781954 ↗ Oct 2023 |
| Modality | Vaccine | “zoster vaccine live” NCT00231816 ↗ |
| Route | Subcutaneous | “0.65 mL subcutaneous injection” NCT00231816 ↗ |