Last updated: 10/07/2026 13:41:19

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

GSK study ID
309768
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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 purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Time to first occurrence of composite 3-point (3P)-MACE

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Secondary outcomes:

Time to first occurrence of composite 5-point (5P)-MACE

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to first occurrence of MI (fatal and non-fatal)

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to first occurrence of stroke (fatal and non-fatal)

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to occurrence of CV death

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to occurrence of all-cause death

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to first occurrence of hospitalization for HF or death due to HF

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Time to first occurrence of hospitalization for UA

Timeframe: From Day 1 to total follow-up time (up to Month 74)

Number of participants reporting any serious adverse events (SAEs)

Timeframe: From Day 1 to Month 14

Number of participants reporting SAEs related to the study intervention or study procedures

Timeframe: From Day 1 to total follow up time (up to Month 74)

Number of participants reporting SAEs leading to withdrawal from the study

Timeframe: From Day 1 to total follow up time (up to Month 74)

Number of participants reporting any medically-attended adverse events (MAAEs)

Timeframe: From Day 1 to Month 14

Number of participants reporting any adverse events of special interest (AESIs)

Timeframe: From Day 1 to Month 14

Interventions:
Combination product: RZV vaccine
Combination product: Placebo
Enrollment:
16390
Primary completion date:
2032-25-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cardiovascular Disease
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2026 to November 2032
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
  • 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.
  • 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.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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