Placebo
Combination ProductPlacebo will be administered intramuscularly.
NCT Number: NCT07712380
This study is designed to evaluate whether the adjuvanted recombinant zoster vaccine (RZV) or the adjuvanted respiratory syncytial virus PreFusion protein 3 (RSVPreF3) vaccine can attenuate the progression of coronary plaque in adult individuals at risk for cardiovascular events.
Trial opening soon.
Get Notified50 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Cardiovascular conditions
Other medical conditions
Prior/Concomitant therapy
Prior/Concurrent clinical study participation
Other exclusion criteria
Placebo will be administered intramuscularly.
Adjuvanted RZV vaccine will be administered intramuscularly.
Adjuvanted RSVPreF3 vaccine will be administered intramuscularly.
Time frame: At Baseline (Day 1) and at Month 14
Time frame: At Baseline (Day 1) and at Month 14
Time frame: At Baseline (Day 1) and at Month 14
Time frame: At Baseline (Day 1) and at Month 14
Time frame: From Day 1 to Month 15
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.
Time frame: From start of screening (Day -15) to Month 15
Time frame: From Day 1 to Month 15
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Randomized, Observer-blind, Placebo-controlled Exploratory Study to Evaluate Whether Administration of Adjuvanted RZV or RSVPreF3 Vaccine Can Attenuate Coronary Plaque Progression in Individuals 50 Years of Age and Above Who Are at Risk for Cardiovascular Events
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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