NCT06634797已完成4 期
A Phase 4, Randomized, Observer-blind, Placebo-controlled, Crossover Study to Assess Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 24
- 主要终点
- Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
研究概览
简要总结
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Investigator's assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
- •Has known history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
- •Has a documented history of myocarditis or pericarditis.
- •Is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) less than 72 hours prior to or at the Screening Visit or Day
- •Has known conditions that may cause elevated cTnI.
- •Cardiac disease/conditions including rhythm disorders and congenital heart disease
- •Uncontrolled hypertension (defined as systolic blood pressure >140 millimeter of mercury (mmHg) or diastolic blood pressure >90 mmHg)
- •Alcohol or substance abuse
- •Kidney disease
- •Severe obesity, defined as body mass index (BMI) ≥40 kilograms per square meter (kg/m^2) (>20 years) or severe obesity defined as BMI for sex and age ≥120% of the 95th percentile [BMI ≥35 kg/m^2] (for 12 to 20 years)
- •Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization for worsening disease, at the discretion of the Investigator.
- •Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- •Reported history of congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV]), immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections disease.
- •History of Guillain-Barré syndrome.
- •Receipt of the following:
- •Coronavirus disease 2019 (COVID-19) vaccine within 3 months prior to the first injection or if planning to receive at any time during the study (except for study intervention).
- •Any other licensed vaccine within 28 days before the study injection or planned receipt prior to end of study (EOS).
- •Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Systemic immunoglobulins or blood products within 3 months prior to the Screening/Baseline Visit or plans for receipt during the study.
研究组 & 干预措施
Sequence 1: mRNA-1273.712 then Placebo
Experimental
Participants will receive mRNA-1273.712 followed by placebo 28 days later.
干预措施: mRNA-1273.712 (Biological)
Sequence 1: mRNA-1273.712 then Placebo
Experimental
Participants will receive mRNA-1273.712 followed by placebo 28 days later.
干预措施: Placebo (Biological)
Sequence 2: Placebo then mRNA-1273.712
Experimental
Participants will receive placebo followed by mRNA-1273.712 28 days later.
干预措施: mRNA-1273.712 (Biological)
Sequence 2: Placebo then mRNA-1273.712
Experimental
Participants will receive placebo followed by mRNA-1273.712 28 days later.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
时间窗: Day 4 and Day 32
Elevated cTnI was defined as \>53.53 picograms per milliliter (pg/mL) in males and \>38.64 pg/mL in females. One participant who was included in the analysis, had an elevation of cTnI pre-injection of study intervention on Day 1 and had a normal value of cTnI pre-injection of study intervention on Day 29. Note that other factors such as physical activity can affect cTnI.
次要结局
- Number of Participants With Elevated cTnI Level at Day 1 (Baseline)(Pre-injection 1: Day 1)
- Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2)(Day 29 and Day 57)
- Number of Participants With Serious Adverse Events (SAEs), Medically-attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), and Adverse Events Leading to Withdrawal(Day 1 up to Day 57)
研究者
研究点 (24)
Loading locations...
相似试验
已完成
不适用
Observational Study on Cardiac Biomarkers Testing in Patients with Muscular Dystrophy CardiomyopathyCardiomyopathiesSkeletal Muscle DisorderNCT05779202University Hospital Heidelberg35
已完成
不适用
Troponin levels in patients undergoing spinal surgery:prone versus supine position.troponin elevationdegenerative spine disorders undergoing a spinal surgical procedureSurgery - Other surgeryCardiovascular - Other cardiovascular diseasesACTRN12616000421437The Townsville Hospital Neurosurgical Department90
Unknown
不适用
Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve SurgeryMyocardial IschemiaNCT02551328Fondazione Toscana Gabriele Monasterio48
终止
不适用
High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest PainChest PainAcute Coronary SyndromeNCT01836211Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau101
已完成
不适用
High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk StratificationChest PainAcute Coronary SyndromeNCT02984436University of Florida1,572