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
Trial overview
Time to first occurrence of composite 3-point (3P)-MACE
Timeframe: From Day 1 to total follow-up time (up to Month 74)
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
- 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.
- 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:
- 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.
Participants, including participants with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
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.
- 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.
- Planned administration/administration of a vaccine in the period starting 30 days before the first dose/each dose and ending 30 days after the last dose/each dose of study intervention(s) administration, with the exception of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine which can be administered up to 14 days before or 14 days after study intervention administration. Inactivated seasonal influenza vaccines can be co-administered or administered at any time. Prior/Concurrent clinical study participation
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention drug/invasive medical device. Other exclusion criteria
- Bedridden participants.
- Pregnant or lactating participant.
- Current/history of alcohol or substance use disorder, based on investigator’s judgment.
- Any study personnel or their immediate dependents, family, or household members.
Cardiovascular conditions
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
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.