TheraRadar
Data updated: May 26, 2026

Shingrix (zoster vaccine recombinant, adjuvanted)

Approved 2017-10-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-10-19
Routes
Intramuscular
Dosage Forms
Injection, For Injection

Companies

GSK
Active Ingredient: Zoster Vaccine Recombinant, Adjuvanted , Zoster Vaccine Recombinant, Adjuvanted , Zoster Vaccine Recombinant, Adjuvanted

Shingrix Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Oct 2017 ORIGINAL
Update · CBER biologic (Purple Book)

What Shingrix Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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Clinical Trial Registry

27 trials
Trial Sponsor ID Phase Status Title
NCT07285265 ABO1108-101 Ph 1 active not recruiting Phase I Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above
NCT05580458 10000866 000866-I Ph 1, Ph 2 recruiting Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
NCT04403139 STUDY00009255 R01AG064800 Ph 4 active not recruiting VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination
NCT05703607 C5031001 NCT05703607 Ph 1, Ph 2 terminated A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
NCT06581575 JCXH-105-021 Ph 2 active not recruiting A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
NCT04128189 19-0005 Ph 3 recruiting Shingrix in Renal Transplant Recipients
NCT06375512 IN001001 Ph 1 completed A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
NCT07481604 CVI-VZV-001-CT2501-B Ph 2 not yet recruiting Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
NCT05170399 10000444 000444-H Ph 4 recruiting Vaccine Responses in Patients With B Cell Malignancies
NCT06569823 DV2-ZOS-02 Ph 1, Ph 2 recruiting Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
NCT07205796 IN001005 Ph 2 not yet recruiting A Phase 2 Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
NCT05304351 CRV-101-101 Ph 2 active not recruiting Safety and Immunogenicity of CRV-101 Vaccine for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
NCT05701800 mRNA-1468-P101 Ph 1, Ph 2 active not recruiting A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
NCT06409494 EuHZV_101 Ph 1 active not recruiting Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years
NCT05550194 VENS_220945 Ph 4 recruiting VZV in the Enteric Nervous System: Pathogenesis and Consequences
NCT03798691 results posted 2018-1037 SMPH/MEDICINE/GASTROENT, A534250 Ph 4 completed Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab
NCT06335849 LYB004-CT-AUS-101 Ph 1 active not recruiting A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years
NCT03591770 results posted H-37673 Ph 4 terminated Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
NCT06763783 HZ-REUMA 2023-506230-71-01 Ph 4 enrolling by invitation Vaccination Against Herpes Zoster in Patients With Inflammatory Rheumatic Diseases
NCT05991427 CTP-CVE-001 Ph 1 completed A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years
NCT06137755 CVI-VZV-001-CT2101 Ph 1 recruiting Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
NCT04169009 results posted 18-0580 1U01AI141919-01 Ph 4 completed Persistence of Protection by Shingrix
NCT05769049 REC610C102 Ph 1 completed The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)
NCT03702231 results posted 190001 19-H-0001 Ph 2 completed Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)
NCT03886038 VACCIMIL-ZOSTER Ph 4 completed Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)
NCT05554068 215468 Ph 2 recruiting Immunogenicity of Zoster Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients
NCT05245838 DV2-ZOS-01 Ph 1 completed Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

Shingrix FDA Label Details

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Data Sources

FDA Approval: BLA125614 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.