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NCT05371080 · ClinicalTrials.gov registry record · Phase 3
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
A Phase 3 study of Herpes Zoster, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 3
- Development phase
- 3,038
- Enrollment target
- 20
- Study locations
NCT05371080: Active Phase 3 study of Herpes Zoster, sponsored by GlaxoSmithKline.
NCT05371080 is a Phase 3 study of Herpes Zoster that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 3,038 participants, above the 1,984-participant average among 16 other Herpes Zoster trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05371080, a Phase 3 study of Herpes Zoster, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,038 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.
Primary Outcome
A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ can be confirmed in two ways: * By PCR; * By the HZ Ascertainment Committee (HZAC).
Conditions Studied
Interventions
- BIOLOGICAL HZ/su vaccine
Study Locations (20)
North Carolina
- GSK Investigational Site - Charlotte
- GSK Investigational Site - Hickory
New South Wales
- GSK Investigational Site - Warrawong
- GSK Investigational Site - Westmead
Other
- GSK Investigational Site - São Paulo
- GSK Investigational Site - São Paulo
British Columbia
- GSK Investigational Site - Vancouver
- GSK Investigational Site - Victoria
Nova Scotia
- GSK Investigational Site - Halifax
- GSK Investigational Site - Truro
Arizona
- GSK Investigational Site - Phoenix
Maryland
- GSK Investigational Site - Elkridge
Pennsylvania
- GSK Investigational Site - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,038 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2027-08-23 |
| Phase | Phase 3 |
What the registry record for NCT05371080 still lists
NCT05371080 is an interventional study that assigns participants to a tested intervention. Its 3,038 participants enrollment target places it among the larger protocols in the corpus, above the 1,984-participant average among 16 other Herpes Zoster trials with a reported enrollment target (53% higher).
The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 1 intervention - of which HZ/su vaccine is the first listed.
NCT05371080 names 20 study sites across 15 states, led by North Carolina, New South Wales, Other.
Frequently Asked Questions
What is clinical trial NCT05371080 about?
NCT05371080 is a clinical study titled "A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults". The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post...
What is the current status of trial NCT05371080?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3,038 participants. The study started on 2022-08-10. Estimated completion is 2027-08-23.
What conditions does trial NCT05371080 study?
This clinical trial studies the following conditions: Herpes Zoster.
What interventions are being tested in trial NCT05371080?
The interventions under investigation include: HZ/su vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05371080?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05371080 being conducted?
This trial has 20 study locations across Arizona, Maryland, North Carolina, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Herpes Zoster
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05371080's enrollment target sits among peer trials
3,038 3rd of 16 higher than 14 of 16 other Herpes Zoster trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Herpes Zoster trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older
COMPLETED · Phase 3
-
Study to Evaluate Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A When Co-administered With Pneumovax 23™ in Adults Aged 50 Years and Older
COMPLETED · Phase 3
-
Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
COMPLETED · Phase 3
-
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
COMPLETED · Phase 3
-
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
RECRUITING · Phase 1
-
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions
ACTIVE NOT RECRUITING
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