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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 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.

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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.

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

FieldValue
Enrollment Target 3,038 participants
Start Date 2022-08-10
Est. Completion 2027-08-23
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT05371080

The ClinicalTrials.gov registry entry for NCT05371080 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 3,038 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,984-participant average among 16 other Herpes Zoster trials with a reported enrollment target (53% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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