Data updated: May 26, 2026
Zostavax (zoster vaccine live)
Approved 2006-05-24
1
Indication
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Disc
- First Approved
- 2006-05-24
- Revenue
- $246M (Q4-2015)
- Routes
- Subcutaneous
- Dosage Forms
- For Injection
Zostavax Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2006 to 2006
May 2006 ORIGINAL
Update · CBER biologic (Purple Book)
What Zostavax Treats
1 FDA approvalsOriginally approved for its first indication in 2006 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2006)
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Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04169009 results posted | 18-0580 1U01AI141919-01 | Ph 4 | completed | Persistence of Protection by Shingrix |
| NCT00851786 results posted | A5247 10519, ACTG A5247 | Ph 2 | completed | Live Zoster Vaccine in HIV-Infected Adults on Antiretroviral Therapy |
| NCT02114333 | 13-3192 | Ph 1 | completed | Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds |
| NCT02624375 results posted | STUDY00001399 53354 | Ph 4 | completed | Immune Response to Shingles Vaccination |
| NCT02329457 VZIDST | HKU 11-174 | Ph 2, Ph 3 | completed | VZV Vaccine for Hematopoietic Stem Cell Transplantation |
| NCT02477150 | NTWC/CREC/15029 | Ph 4 | completed | Safety and Immunogenicity of a Zoster Vaccine in SLE |
| NCT01391546 results posted | V211-045 ZTV03C, V211-045 | Ph 3 | completed | Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045) |
| NCT01527370 results posted | V211-025 CTRI/2012/08/002922 | Ph 3 | completed | Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) |
| NCT01573182 VZV-Zostavax | VADOVAR | Ph 2 | completed | Herpes Zoster Vaccine for Bone Marrow Transplant Donors |
| NCT02958345 results posted | 13-356128 | Ph 4 | completed | Placebo Controlled Evaluation of the Cell Mediated Immune Response of Cirrhotic Subjects to Zostavax™ |
| NCT03121638 | NBP608_VZ_I_2012 | Ph 1 | completed | Safety Study of NBP608 in Healthy Adult Volunteers |
| NCT03120364 | NBP608_HZ_III_2015 | Ph 3 | completed | Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over |
| NCT03116594 | NBP608_HZ_III_2013 | Ph 2, Ph 3 | completed | Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over |
| NCT01556451 results posted | V211-034 | Ph 4 | completed | ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034) |
| NCT01213810 | SHCS 610 | Ph 1, Ph 2 | withdrawn | Prevention of Varicella Zoster Virus (VZV)-Reactivation in HIV-positive Individuals Enrolled in a Prospective Immunogenicity and Safety Trial of VZV Vaccine: PROVE-IT-Study |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Zostavax FDA Label Details
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Revenue Insights
- • Q4-2015: $246M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.