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

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524598-17-00

Enrollment

35000

Registered

2026-02-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incident dementia

Brief summary

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

Detailed description

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

Interventions

DRUGShingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant

DRUGadjuvanted)

DRUGThe Placebo used for the clinical trial is a sterile saline solution (0.9% w/v solution of NaCl in water) supplied in 1.25 mL pre-filled glass syringes.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incident diagnosis of dementia post-first dose of Shingrix or placebo.	—

Secondary

Measure	Time frame
1. Incident diagnosis of AD post-first dose of Shingrix or placebo.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 17, 2026