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

NCT06634797 | Completed Phase 4 Results FDA Drug

• 1 other identifier: mRNA-1273-P404
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

mRNA-1273.712; Vaccine; Cardiac Troponin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)

  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.

  Day 4 and Day 32

Secondary Outcomes (3)

• 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

Study Arms (2)

Sequence 1: mRNA-1273.712 then Placebo

EXPERIMENTAL

Participants will receive mRNA-1273.712 followed by placebo 28 days later.

Biological: mRNA-1273.712; Biological: Placebo

Sequence 2: Placebo then mRNA-1273.712

EXPERIMENTAL

Participants will receive placebo followed by mRNA-1273.712 28 days later.

Biological: mRNA-1273.712; Biological: Placebo

Interventions

mRNA-1273.712 BIOLOGICAL

Intramuscular (IM) injection.

Sequence 1: mRNA-1273.712 then Placebo; Sequence 2: Placebo then mRNA-1273.712

Placebo BIOLOGICAL

Sodium chloride for IM injection.

Sequence 1: mRNA-1273.712 then Placebo; Sequence 2: Placebo then mRNA-1273.712

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (24)

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006, United States

Location

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

Location

Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States

Location

Velocity Clinical Research, Banning

San Bernardino, California, 82408, United States

Location

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia, 20016, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research, Covington

Covington, Louisiana, 70433, United States

Location

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508, United States

Location

Velocity Clinical Research, New Orleans

New Orleans, Louisiana, 70119, United States

Location

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, 39503, United States

Location

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research, Lincoln

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research, Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Velocity Clinical Research, Syracuse

East Syracuse, New York, 13057, United States

Location

Velocity Clinical Research, Durham

Durham, North Carolina, 27701, United States

Location

Velocity Clinical Research, Cleveland

Beachwood, Ohio, 44122, United States

Location

Velocity Clinical Research, Cincinnati, Blue Ash

Blue Ash, Ohio, 45242, United States

Location

Velocity Clinical Research, Cincinnati

Cincinnati, Ohio, 45246, United States

Location

Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research, Abilene

Abilene, Texas, 79606, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 8, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2025-11

Locations

US (24)