Recruiting NCT07502560
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Recombinant zoster vaccine, Placebo.
- Who it may be relevant to
- Registry conditions: Herpes Zoster. Basic parameters: from 76 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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. - 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).
Primary outcome measures
- 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]
Secondary outcome measures (2)
- 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Finland · 8 centers
- GSK Investigational Site — Espoo
- GSK Investigational Site — Helsinki
- GSK Investigational Site — Jarvenpaa
- GSK Investigational Site — Kokkola
- GSK Investigational Site — Oulu
- GSK Investigational Site — Seinäjoki
- GSK Investigational Site — Tampere
- GSK Investigational Site — Turku
Identifiers
NCT: NCT07502560 · 300889 · 2025-524598-17-00