Clinical trial NCT06634797: A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: mRNA-1273.712
Vaccine
Cardiac Troponin
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Investigator's assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
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:

1. 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.
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.

Primary outcomes:
measure: Number of Participants with Elevated cTnI Levels at Day 4
timeFrame: Day 4
measure: Number of Participants with Elevated cTnI Levels at Day 32
timeFrame: Day 32
Secondary outcomes:
measure: Number of Participants with Elevated cTnI Levels at Day 1
timeFrame: Day 1
measure: Number of Participants with Elevated cTnI Levels at Day 29 or Day 57
timeFrame: Day 29, Day 57
measure: Number of Participants with Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESI) and Adverse Events Leading to Withdrawal Throughout the Study
timeFrame: Up to approximately 2 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Velocity Clinical Research, Phoenix
state: Arizona
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: San Bernardino
country: United States
facility: Velocity Clinical Research, Banning
state: California
city: Washington
country: United States
facility: Velocity Clinical Research, Washington DC
state: District of Columbia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Valparaiso
country: United States
facility: Velocity Clinical Research, Valparaiso
state: Indiana
city: Covington
country: United States
facility: Velocity Clinical Research, Covington
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research, New Orleans
state: Louisiana
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport
state: Mississippi
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research, Lincoln
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Albuquerque
country: United States
facility: Velocity Clinical Research, Albuquerque
state: New Mexico
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Durham
country: United States
facility: Velocity Clinical Research, Durham
state: North Carolina
city: Beachwood
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Blue Ash
country: United States
facility: Velocity Clinical Research, Cincinnati, Blue Ash
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati
state: Ohio
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson
state: South Carolina
city: Abilene
country: United States
facility: Velocity Clinical Research, Abilene
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
Study officials:
References: