Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults
NCT05371080 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05371080
The ClinicalTrials.gov registry entry for NCT05371080 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,038 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05371080 reports 20 study locations spanning 15 distinct geographic areas — top geographies include North Carolina, New South Wales, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05371080?
The interventions under investigation include: HZ/su vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05371080?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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