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

Condition studied

Herpes Zoster

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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