A phase IV trial of Shingrix on incident dementia diagnosis in adults aged ≥76 years in Finland

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Healthy volunteers

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Biologicals SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

1. To assess the effect of Shingrix on the risk reduction of an incident dementia diagnosis among adults ≥ 76 years, compared to placebo.

Secondary objectives 2

1. 1. To assess the effect of a 2-dose Shingrix regimen on the risk reduction of an incident dementia diagnosis among adults aged ≥76 years, compared to placebo.
2. 2. To assess the effect of Shingrix on the risk of an incident AD diagnosis among adults ≥ 76 years, compared to placebo.

Conditions and MedDRA coding

Incident dementia

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Finnish Medicines Agency

Plan to share 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://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf o 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. o 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants are eligible to be included in the study only if ALL of the following criteria apply: 1. Citizens living permanently in Finland, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits).
2. 2. Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.
3. 3. Age 76 years or older at the time of signing the informed consent.

Exclusion criteria 6

1. Participants will be excluded from the study if any of the following criteria apply: 1. History of vaccination against HZ
2. 2. History of dementia prior to enrolment, including confirmed cases or those under investigation. This includes: a) History of a confirmed clinical diagnosis of dementia prior to enrolment b) Prior or current use of medications intended to treat dementia c) Current or recent history of cognitive assessments for any memory deficit or suspected dementia before enrollment including investigations that are ongoing or were inconclusive (but not those for which dementia was conclusively ruled out); MCI on its own without any other information to indicate cognitive decline or dementia will not result in exclusion
3. 3. Severely immunocompromised individuals (i.e., those with haematological cancer or have had stem cell transplant or organ transplant)
4. 4. Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational product
5. 5. 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
6. 6. Living in a nursing facility

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Incident diagnosis of dementia post-first dose of Shingrix or placebo.

Secondary endpoints 2

1. 1. Incident diagnosis of dementia occurring 1 month post-second dose of Shingrix or placebo.
2. 2. Incident diagnosis of AD post-first dose of Shingrix or placebo.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 2

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications