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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33,609 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 76 Years
• Healthy volunteers: Accepted

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-03-31
• Primary completion: 2030-03-29
• Completion: 2037-03-31
• First posted: 2026-03-31
• Last updated: 2026-03-31