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Phase 4 N=1,000 Randomized Triple-blind Basic Science

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

Healthy Volunteers

Enrolled (actual)
1,000
Serious AEs
0.1%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) — 1; 0 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
mRNA-1273.712 (Biological); Placebo (Biological)
Age
Pediatric, Adult · 12+ yrs
Sex
All
Sponsor
ModernaTX, Inc.
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
1; 0
SECONDARY
Number of Participants With Elevated cTnI Level at Day 1 (Baseline)
2; 5
SECONDARY
Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2)
4; 8
SECONDARY
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
0; 0; 0; 1; 6; 5

Summary

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

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06634797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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