Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Cardiovascular diseaseCardiovascular risk factorsMajor adverse cardiovascular eventsPublic healthRecombinant zoster vaccine

Outcome Measures

Primary Outcomes (1)

Time to first occurrence of composite 3-point (3P)-MACE
3P-MACE is defined as a confirmed composite endpoint consisting of non-fatal myocardial infarction (MI), non-fatal stroke or cardiovascular (CV) death.
From Day 1 to total follow-up time (up to Month 74)

Secondary Outcomes (12)

Time to first occurrence of composite 5-point (5P)-MACE
From Day 1 to total follow-up time (up to Month 74)
Time to first occurrence of MI (fatal and non-fatal)
From Day 1 to total follow-up time (up to Month 74)
Time to first occurrence of stroke (fatal and non-fatal)
From Day 1 to total follow-up time (up to Month 74)
Time to occurrence of CV death
From Day 1 to total follow-up time (up to Month 74)
Time to occurrence of all-cause death
From Day 1 to total follow-up time (up to Month 74)
+7 more secondary outcomes

Study Arms (2)

RZV Group

EXPERIMENTAL

Participants receive 2 doses of RZV vaccine, the first dose being administered at Day 1 and the second dose at Month 2.

Combination Product: RZV vaccine

Placebo Group

PLACEBO COMPARATOR

Participants receive 2 doses of placebo, the first dose being administered at Day 1 and the second dose at Month 2.

Combination Product: Placebo

Interventions

RZV vaccineCombination product

RZV vaccine will be administered intramuscularly.

Also known as: Shingrix

RZV Group

PlaceboCombination product

Placebo will be administered intramuscularly.

Placebo Group

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

GlaxoSmithKline
Industrylead

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: The study will be conducted in an observer-blind manner.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2026

First Posted

October 13, 2026

Study Start

November 30, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

You may not qualify if:

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 \<=5 years prior to signing informed consent.
Prior/Concomitant therapy
Previous vaccination against HZ (investigational or licensed vaccine) and/or planned administration of vaccination against HZ during the study period other than the vaccine administered during the study.
Use of any investigational or non-registered product other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.
Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
+7 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

RZV Group

Placebo Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

RZV Group

Placebo Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record