A Study to Evaluate the Effect of Recombinant Zoster Vaccine on New Diagnosis of Dementia in an Older Adult Population Aged 76 Years or Older in Finland

May 8, 2026 updated by: GlaxoSmithKline

A Randomized, Placebo Controlled, Observer-blind, Phase IV Pragmatic Trial to Evaluate the Effect of Recombinant Zoster Vaccine (Shingrix) on Incident Dementia Diagnosis in an Older Adult Population Aged ≥76 Years in Finland

The purpose of this study is to evaluate the effect of the recombinant zoster vaccine on the risk of new diagnosis of dementia among adults aged 76 years or older in Finland. Participants will be enrolled and randomized in a 3:1 ratio to receive either recombinant zoster vaccine or placebo.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33609

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Espoo, Finland, 02230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Helsinki, Finland, 00100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Jarvenpaa, Finland, 04400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Kokkola, Finland, 67100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Oulu, Finland, 90220
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Seinäjoki, Finland, 60100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Tampere, Finland, 33100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu
      • Turku, Finland, 20520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arto Palmu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. Informed consent will include consent to access health register data for participants.
  • Age 76 years or older at the time of signing the informed consent.

Exclusion Criteria:

  • Prior receipt of a Herpes Zoster (HZ) vaccine.

  • History of dementia diagnosis prior to enrolment, including confirmed cases or those under investigation. This includes:

    • History of a confirmed clinical diagnosis of dementia prior to enrolment.
    • Prior or current use of medications intended to treat dementia.
    • Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrolment including investigations that are ongoing or that were inconclusive (but not those for which dementia was conclusively ruled out); mild cognitive impairment on its own without any other information to indicate cognitive decline or dementia will not result in exclusion.
  • Severely immunocompromised individuals.
  • Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product or ongoing participation in trials focused on preventive dementia interventions.
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
  • Living in a nursing facility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recombinant zoster vaccine Group
Participants in this group receive recombinant zoster vaccine, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule.
Biological: Recombinant zoster vaccine
Recombinant zoster vaccine administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose), according to the approved recombinant zoster vaccine dosing schedule.
Other Names:
  • Shingrix
Placebo Comparator: Placebo Group
Participants in this group receive placebo, the first dose being administered at Visit 1 (Day 1) and the second dose at Visit 2 (between 2 and 6 months after the first dose).
Drug: Placebo
Placebo administered intramuscularly, one dose at Visit 1 (Day 1) and one dose at Visit 2 (between 2 and 6 months after the first dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazard ratio of incident dementia diagnosis
Time Frame: From first dose of study intervention (Day 1) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.
From first dose of study intervention (Day 1) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hazard ratio of incident Alzheimer's disease diagnosis
Time Frame: From first dose of study intervention (Day 1) until the date of first Alzheimer's disease diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Alzheimer's disease diagnosis is defined as the first-time diagnosis of Alzheimer's disease as identified during the follow-up period.
From first dose of study intervention (Day 1) until the date of first Alzheimer's disease diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Hazard ratio of incident dementia diagnosis
Time Frame: From 1 month after second dose of study intervention (2 to 6 months after first dose of study intervention) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years
Dementia diagnosis is defined as the first-time diagnosis of dementia as identified during the follow-up period.
From 1 month after second dose of study intervention (2 to 6 months after first dose of study intervention) until the date of first dementia diagnosis, death, loss to follow-up, or end of data availability, whichever occurs first, assessed up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Finnish Vaccine Research;
Dr Arto Palmu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

March 31, 2037

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300889
  • 2025-524598-17-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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