A Pragmatic Randomized Trial to Evaluate the Effect of Recombinant Herpes Zoster Vaccine on Major Adverse Cardiovascular Events and Dementia in Adults Aged 65 Years or Above

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524944-37-00

Enrollment

162000

Registered

2026-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-04

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

Conditions

Herpes Zoster

Brief summary

In line with the study’s primary objective of evaluating the effect of Shingrix® on the risk of MACE and new dementia in adults aged 65 years and older, this trial includes the following dual primary time-to-event endpoints: 1) Hospitalization for MACE 2) new dementia

Detailed description

The secondary endpoints of this trial are subdivided according to the dual primary endpoints of MACE and new dementia., MACE-related secondary endpoints The MACE related secondary endpoints are as follows: -Composite of hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death -Hospitalization for any cardiovascular disease -Hospitalization for stroke -Hospitalization for myocardial infarction -Cardiovascular death Dementia-related secondary endpoints The new dementia related endpoints are as follows: – Alzheimer’s dementia – Vascular dementia – Unspecified dementia

Interventions

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

DRUGadjuvanted)

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
In line with the study’s primary objective of evaluating the effect of Shingrix® on the risk of MACE and new dementia in adults aged 65 years and older, this trial includes the following dual primary time-to-event endpoints: 1) Hospitalization for MACE 2) new dementia	—

Secondary

Measure	Time frame
The secondary endpoints of this trial are subdivided according to the dual primary endpoints of MACE and new dementia., MACE-related secondary endpoints The MACE related secondary endpoints are as follows: -Composite of hospitalization for non-fatal acute coronary syndrome, non-fatal stroke, or cardiovascular death -Hospitalization for any cardiovascular disease -Hospitalization for stroke -Hospitalization for myocardial infarction -Cardiovascular death Dementia-related secondary endpoints The new dementia related endpoints are as follows: – Alzheimer’s dementia – Vascular dementia – Unspecified dementia	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 5, 2026