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

Last updated: May 8, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

4

Condition

Herpes Simplex Infections

Chickenpox (Varicella Zoster Infection)

Shingles

Treatment

Placebo

Recombinant zoster vaccine

Clinical Study ID

NCT07502560
300889
2025-524598-17-00
  • Ages > 76
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Citizens living permanently in Finland, who, in the opinion of the investigator, canand will comply with the requirements of the protocol.

  • Written or witnessed informed consent obtained from the participant prior toperformance of any study-specific procedure. Informed consent will include consentto access health register data for participants.

  • Age 76 years or older at the time of signing the informed consent.

Exclusion

Exclusion Criteria:

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

  • History of dementia diagnosis prior to enrolment, including confirmed cases or thoseunder 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 orsuspected dementia before enrolment including investigations that are ongoingor that were inconclusive (but not those for which dementia was conclusivelyruled out); mild cognitive impairment on its own without any other informationto indicate cognitive decline or dementia will not result in exclusion.

  • Severely immunocompromised individuals.

  • Concurrently participating in another clinical trial, in which the participant hasbeen or will be exposed to an investigational product or ongoing participation intrials focused on preventive dementia interventions.

  • Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccines used in the study or to a vaccinecontaining any of the same substances.

  • Living in a nursing facility.

Study Design

Total Participants: 33609
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
March 31, 2026
Estimated Completion Date:
March 31, 2037

Connect with a study center

  • GSK Investigational Site

    Espoo, 02230
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Helsinki, 00100
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Jarvenpaa, 04400
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Kokkola, 67100
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Oulu, 90220
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Seinäjoki, 60100
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Tampere, 33100
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Turku, 20520
    Finland

    Active - Recruiting

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