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Not Yet Recruiting NCT07872046

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

Conditions: Cardiovascular Disease

Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 16390
Sponsor: GlaxoSmithKline

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Participants, including participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. * Medically stable patients as established by medical history and clinical examination at screening. * Male or female participants \>=50 years of age (YOA) at the time of the first study intervention administration. * Participants with documented history of, and medically managed with standard of care (SOC) pharmacotherapy according to local clinical practice for: \- Two or more risk factors for CVD, OR o Participants with established CVD, including \>=1 of the following: 1. Coronary artery disease. 2. Peripheral artery disease. 3. Cerebrovascular disease. * Participants of non-childbearing potential may be enrolled in the clinical study. * Participant of childbearing potential (POCBP) may be enrolled in the study if the participant: * has practiced adequate contraception for at least 30 days prior to study intervention administration, and * has a negative pregnancy test within 24 hours prior to the study intervention administration, and * has agreed to continue adequate contraception during the entire treatment period and for 8 weeks after completion of the study intervention administration series. Exclusion Criteria: Cardiovascular conditions • Prior CVD event or hospitalization for UA within 3 months of the screening visit or CVD expected to require surgical intervention within 6 months after vaccine administration. Other medical conditions * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Uncontrolled or unstable chronic conditions including New York Heart Association (NYHA) Class IV heart failure, clinically significant pulmonary, CV, hepatic, or renal functional abnormality, as determined by medical history and clinical examination. * Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. * Condition that in the judgment of the investigator would make intramuscular injection unsafe. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * History of malignancy \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07872046). StuddyBuddy aggregates publicly available trial information.