Phase 3Not yet recruiting
A Study on the Impact of Recombinant Zoster Vaccine on Major Adverse Cardiovascular Events in Adults >=50 Years of Age With Established Cardiovascular Disease or With >=2 Cardiovascular Risk Factors
A Phase 3a Observer-blind, Randomized, Placebo-controlled, Multi-country Study to Evaluate the Impact of Recombinant Zoster Vaccine on Major Adverse Cardiovascular Events in Adults >=50 Years of Age With Established Cardiovascular Disease or With >=2 Cardiovascular Risk Factors
- Sponsor
- GlaxoSmithKline (Industry)
- Enrolment
- 16,390 planned
- Conditions
- Cardiovascular Disease
- Interventions
- RZV vaccine; Placebo
- Ages
- adults, older adults
- Registry
- NCT07872046, CTIS2026-527478-35-00
Full record on ClinicalTrials.gov
From the registry
This study aims to evaluate the effect of the recombinant zoster vaccine (RZV) on the occurrence of clinically important cardiovascular (heart and blood vessel) events, with a focus on major adverse cardiovascular events (MACE), in adults with established cardiovascular disease (CVD) or with 2 or more CV risk factors. Participants will be randomized to receive either RZV or placebo.
Primary outcomes
- Time to first occurrence of composite 3-point (3P)-MACE
History
Primary completion expected
Expected to start
Registered