A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.

Key facts

Study ID

NCT06634797

Run by

ModernaTX, Inc.

People needed

1000

Starts

2024-10-08

Expected to finish

2025-01-20

Last updated by the study team

2026-02-04

Who can join

Age: 12 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 1.
• Has known conditions that may cause elevated cTnI.
• Cardiac disease/conditions including rhythm disorders and congenital heart disease
• Diabetes
• 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.

Where it is running

• Velocity Clinical Research, Phoenix — Phoenix, Arizona, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Velocity Clinical Research, San Diego — La Mesa, California, United States
• Velocity Clinical Research, Banning — San Bernardino, California, United States
• Velocity Clinical Research, Washington DC — Washington D.C., District of Columbia, United States
• Velocity Clinical Research, Savannah — Savannah, Georgia, United States
• Velocity Clinical Research, Boise — Meridian, Idaho, United States
• Velocity Clinical Research, Valparaiso — Valparaiso, Indiana, United States
• Velocity Clinical Research, Covington — Covington, Louisiana, United States
• Velocity Clinical Research, Lafayette — Lafayette, Louisiana, United States
• Velocity Clinical Research, New Orleans — New Orleans, Louisiana, United States
• Velocity Clinical Research, Gulfport — Gulfport, Mississippi, United States
• Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States
• Velocity Clinical Research, Lincoln — Lincoln, Nebraska, United States
• Velocity Clinical Research, Omaha — Omaha, Nebraska, United States
• Velocity Clinical Research, Albuquerque — Albuquerque, New Mexico, United States
• Velocity Clinical Research, Syracuse — East Syracuse, New York, United States
• Velocity Clinical Research, Durham — Durham, North Carolina, United States
• Velocity Clinical Research, Cleveland — Beachwood, Ohio, United States
• Velocity Clinical Research, Cincinnati, Blue Ash — Blue Ash, Ohio, United States
• Velocity Clinical Research, Cincinnati — Cincinnati, Ohio, United States
• Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
• Velocity Clinical Research, Abilene — Abilene, Texas, United States
• Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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