A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
NCT ID: NCT06634797
Last Updated: 2026-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2024-10-08
2025-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Sequence 1: mRNA-1273.712 then Placebo
Participants will receive mRNA-1273.712 followed by placebo 28 days later.
mRNA-1273.712
Intramuscular (IM) injection.
Placebo
Sodium chloride for IM injection.
Sequence 2: Placebo then mRNA-1273.712
Participants will receive placebo followed by mRNA-1273.712 28 days later.
mRNA-1273.712
Intramuscular (IM) injection.
Placebo
Sodium chloride for IM injection.
Interventions
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mRNA-1273.712
Intramuscular (IM) injection.
Placebo
Sodium chloride for IM injection.
Eligibility Criteria
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Inclusion Criteria
2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
3. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
2. Has known history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
3. Has a documented history of myocarditis or pericarditis.
4. 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.
5. 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)
6. 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.
7. 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.
8. Reported history of congenital or acquired immunodeficiency (eg, human immunodeficiency virus \[HIV\]), immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections disease.
9. History of Guillain-Barré syndrome.
10. 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.
12 Years
30 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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mRNA-1273-P404
Identifier Type: -
Identifier Source: org_study_id
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