Healthy VolunteersPhase 4NCT06634797
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
A Phase 4 study testing mRNA-1273.712 in people with Healthy Volunteers, run by ModernaTX, Inc. at 24 sites in United States.
Trial summary
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- mRNA-1273.712
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 24 sitesUnited States
- Study dates
- 8 Oct 2024to 20 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Velocity Clinical Research, Abilene
Abilene, Texas, 79606
Velocity Clinical Research, Albuquerque
Albuquerque, New Mexico, 87107
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621
Velocity Clinical Research, Cleveland
Beachwood, Ohio, 44122
Velocity Clinical Research, Cincinnati, Blue Ash
Blue Ash, Ohio, 45242
Velocity Clinical Research, Cincinnati
Cincinnati, Ohio, 45246
Velocity Clinical Research, Covington
Covington, Louisiana, 70433
Velocity Clinical Research, Durham
Durham, North Carolina, 27701
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803
Velocity Clinical Research, Gulfport
Gulfport, Mississippi, 39503
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, 70508
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, 68510
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
Velocity Clinical Research, New Orleans
New Orleans, Louisiana, 70119
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Velocity Clinical Research, Phoenix
Phoenix, Arizona, 85006
Velocity Clinical Research, Banning
San Bernardino, California, 82408
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, 20016
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
About this study
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
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
- Being tested
- mRNA-1273.712, Placebo
- Keywords
- mRNA-1273.712, Vaccine, Cardiac Troponin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273.712Biological
Intramuscular (IM) injection.
PlaceboBiological
Sodium chloride for IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: mRNA-1273.712 then Placebo | Experimental | Participants will receive mRNA-1273.712 followed by placebo 28 days later. Receives: 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. Receives: Biological: mRNA-1273.712; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 4 and Day 32
Secondary outcomes (3)
Number of Participants With Elevated cTnI Level at Day 1 (Baseline)
Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females.
Measured: 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)
Elevated cTnI was defined as >53.53 pg/mL in males and >38.64 pg/mL in females.
Measured: 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
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in birth defects or was an important medical event. A MAAE was defined as an AE that led to an unscheduled visit to a healthcare practitioner. Investigators reported AEs as AESIs based on pre-defined criteria. All suspected cases of cardiomyopathy and non-infectious myocarditis, pericarditis, and myopericarditis were reported as AESIs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' module.
Measured: Day 1 up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start8 Oct 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634797
- Sponsor's protocol ID
- mRNA-1273-P404
- Status last verified
- Nov 2025
- First submitted
- 8 Oct 2024
- Last updated
- 4 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06634797
- Acronym / sponsor ID
- mRNA-1273-P404
- Conditions
- Healthy Volunteers
- Keywords
- mRNA-1273.712, Vaccine, Cardiac Troponin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Posted 4 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: mRNA-1273.712 then Placebo | Experimental | Biological: mRNA-1273.712, Biological: PlaceboParticipants will receive mRNA-1273.712 followed by placebo 28 days later. |
| Sequence 2: Placebo then mRNA-1273.712 | Experimental | Biological: mRNA-1273.712, Biological: PlaceboParticipants will receive placebo followed by mRNA-1273.712 28 days later. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1273.712Intramuscular (IM) injection. | Biological | Sequence 1: mRNA-1273.712 then Placebo, Sequence 2: Placebo then mRNA-1273.712 |
| PlaceboSodium chloride for IM injection. | Biological | Sequence 1: mRNA-1273.712 then Placebo, Sequence 2: Placebo then mRNA-1273.712 |
Primary outcome
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
Time frame: Day 4 and Day 32
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.
3 secondary outcomes
Number of Participants With Elevated cTnI Level at Day 1 (Baseline)
Time frame: 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)
Time frame: 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
Time frame: Day 1 up to Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mRNA-1273.712 in people with Healthy Volunteers, run by ModernaTX, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) (time frame: Day 4 and Day 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.