Trial · NCT06634797
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
NCT06634797, Phase 4, Completed, ModernaTX, Inc.; results first posted 2026-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age. Trials, record NCT06634797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06634797
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
- NCT number
- NCT06634797
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,000 participants, actual
- Lead sponsor
- ModernaTX, Inc.
- Conditions
- Healthy Volunteers
- Interventions
- mRNA-1273.712, Placebo
- First posted
- 2024-10-10
- Last updated
- 2026-02-04
- Results first posted
- 2026-02-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | 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. |
| Secondary | Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Pre-injection 1: Day 1 | Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females. |
| Secondary | 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 | Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females. |
| 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 | Day 1 up to Day 57 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Day 4 and Day 32 | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with normal cTnI at pre-injection at either Day 1 or Day 29 and non-missing cTnI at both pre-injection and 3 days after any injection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Pre-injection 1: Day 1 | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with non-missing cTnI at Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Evaluable Set: All randomized participants who received at least 1 study injection who had no major protocol deviations or conditions/medications that impacted critical or key analysis data. The 'number of participants analysed' includes the number of participants with normal cTnI at pre-injection and non-missing cTnI at both pre-injection and 28 days after any injection. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Day 1 up to Day 57 | Safety Set: All randomized participants who received at least 1 study injection. Data were collected and presented by study intervention sequence, and treatment received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | mRNA-1273.712 | 1 | Participants | ||
| Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Placebo | 0 | Participants | ||
| Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Sequence 1: mRNA-1273.712 Then Placebo | 2 | Participants | ||
| Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Sequence 2: Placebo Then mRNA-1273.712 | 5 | Participants | ||
| Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) | mRNA-1273.712 | 4 | Participants | ||
| Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) | Placebo | 8 | Participants | ||
| 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 | Sequence 1 (mRNA-1273.712 - Placebo): mRNA-1273.712 | SAEs | 0 | Participants | |
| 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 | Sequence 1 (mRNA-1273.712 - Placebo): Placebo | SAEs | 0 | Participants | |
| 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 | Sequence 2 (Placebo - mRNA-1273.712): Placebo | SAEs | 0 | Participants | |
| 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 | Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712 | SAEs | 1 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1: mRNA-1273.712 Then Placebo | 500 | |
| Overall Study | STARTED | Sequence 2: Placebo Then mRNA-1273.712 | 500 | |
| Overall Study | Received Study Vaccination | Sequence 1: mRNA-1273.712 Then Placebo | 500 | |
| Overall Study | Received Study Vaccination | Sequence 2: Placebo Then mRNA-1273.712 | 497 | |
| Overall Study | COMPLETED | Sequence 1: mRNA-1273.712 Then Placebo | 438 | |
| Overall Study | COMPLETED | Sequence 2: Placebo Then mRNA-1273.712 | 424 | |
| Overall Study | NOT COMPLETED | Sequence 1: mRNA-1273.712 Then Placebo | 62 | |
| Overall Study | NOT COMPLETED | Sequence 2: Placebo Then mRNA-1273.712 | 76 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Suicidal Ideation | Psychiatric disorders | mRNA-1273.712 - Placebo Sequence: mRNA-1273.712 | 0 | 500 | 0 |
| serious | Suicidal Ideation | Psychiatric disorders | mRNA-1273.712 - Placebo Sequence: Placebo | 0 | 460 | 0 |
| serious | Suicidal Ideation | Psychiatric disorders | Placebo - mRNA-1273.712 Sequence: Placebo | 0 | 497 | 0 |
| serious | Suicidal Ideation | Psychiatric disorders | Placebo - mRNA-1273.712: mRNA-1273.712 | 1 | 454 | 1 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | mRNA-1273.712 - Placebo Sequence: mRNA-1273.712 | 0 | 500 |
| Total, all-cause mortality | mRNA-1273.712 - Placebo Sequence: Placebo | 0 | 460 |
| Total, all-cause mortality | Placebo - mRNA-1273.712 Sequence: Placebo | 0 | 497 |
| Total, all-cause mortality | Placebo - mRNA-1273.712: mRNA-1273.712 | 0 | 454 |
| Total, other adverse events | mRNA-1273.712 - Placebo Sequence: mRNA-1273.712 | 0 | 500 |
| Total, other adverse events | mRNA-1273.712 - Placebo Sequence: Placebo | 0 | 460 |
| Total, other adverse events | Placebo - mRNA-1273.712 Sequence: Placebo | 0 | 497 |
| Total, other adverse events | Placebo - mRNA-1273.712: mRNA-1273.712 | 0 | 454 |
| Total, serious adverse events | mRNA-1273.712 - Placebo Sequence: mRNA-1273.712 | 0 | 500 |
| Total, serious adverse events | mRNA-1273.712 - Placebo Sequence: Placebo | 0 | 460 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sequence 1: mRNA-1273.712 Then Placebo vs Sequence 2: Placebo Then mRNA-1273.712: Number of Participants With Elevated cTnI Level at Day 1 (Baseline) | Trial comparisons |
| mRNA-1273.712 vs Placebo: Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2) | Trial comparisons |
| mRNA-1273.712 vs Placebo: Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06634797
GET https://conductscience.org/api/trials/v1/NCT06634797/results?page=2