NCT07502560

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33,609

participants targeted

Target at P75+ for phase_4

Timeline
132mo left

Started Mar 2026

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Mar 2026Mar 2037

First Submitted

Initial submission to the registry

March 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 31, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2037

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

March 25, 2026

Last Update Submit

May 8, 2026

Conditions

Herpes Zoster

Keywords

Recombinant Zoster VaccineShingrixHerpes ZosterIncident dementiaAlzheimer's DiseaseOlder adultsFinland

Outcome Measures

Primary Outcomes (1)

  • Hazard ratio of incident dementia diagnosis

    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 Outcomes (2)

  • Hazard ratio of incident dementia diagnosis

    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

  • Hazard ratio of incident Alzheimer's disease diagnosis

    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

Study Arms (2)

Recombinant zoster vaccine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Recombinant zoster vaccineBIOLOGICAL

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.

Also known as: Shingrix
Recombinant zoster vaccine Group
PlaceboDRUG

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).

Placebo Group

Eligibility Criteria

Age76 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Investigational Site

Espoo, 02230, Finland

RECRUITING

GSK Investigational Site

Helsinki, 00100, Finland

RECRUITING

GSK Investigational Site

Jarvenpaa, 04400, Finland

RECRUITING

GSK Investigational Site

Kokkola, 67100, Finland

RECRUITING

GSK Investigational Site

Oulu, 90220, Finland

RECRUITING

GSK Investigational Site

Seinäjoki, 60100, Finland

RECRUITING

GSK Investigational Site

Tampere, 33100, Finland

RECRUITING

GSK Investigational Site

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Herpes ZosterAlzheimer Disease

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data will be collected in an observer-blinded fashion.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

March 31, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

March 31, 2037

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.
More information

Locations

FI(8)