Trial Outcomes & Findings for A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age (NCT NCT06634797)
NCT ID: NCT06634797
Last Updated: 2026-02-04
Results Overview
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.
COMPLETED
PHASE4
1000 participants
Day 4 and Day 32
2026-02-04
Participant Flow
Participants were randomized in a 1:1 ratio (500 participants in each injection sequence) to receive 2 study injections (mRNA-1273.712 and placebo) in a crossover design.
Participant milestones
| Measure |
Sequence 1: mRNA-1273.712 Then Placebo
Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.
|
Sequence 2: Placebo Then mRNA-1273.712
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
500
|
500
|
|
Overall Study
Received Study Vaccination
|
500
|
497
|
|
Overall Study
COMPLETED
|
438
|
424
|
|
Overall Study
NOT COMPLETED
|
62
|
76
|
Reasons for withdrawal
| Measure |
Sequence 1: mRNA-1273.712 Then Placebo
Participants received mRNA-1273.712 as an intramuscular (IM) injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.
|
Sequence 2: Placebo Then mRNA-1273.712
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.
|
|---|---|---|
|
Overall Study
Other Than Specified
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
21
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
46
|
48
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Screen Failure
|
0
|
2
|
Baseline Characteristics
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
Baseline characteristics by cohort
| Measure |
Sequence 1: mRNA-1273.712 Then Placebo
n=500 Participants
Participants received mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received placebo matched to mRNA-1273.712 as an IM injection on Day 29 of the study.
|
Sequence 2: Placebo Then mRNA-1273.712
n=500 Participants
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 of the study. Participants then received mRNA-1273.712 as an IM injection on Day 29 of the study.
|
Total
n=1000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.7 years
STANDARD_DEVIATION 5.73 • n=41 Participants
|
20.0 years
STANDARD_DEVIATION 5.71 • n=1581 Participants
|
19.8 years
STANDARD_DEVIATION 5.72 • n=4626 Participants
|
|
Age, Customized
In utero
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
Preterm newborn infants (gestational age < 37 wks)
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
Newborns (0-27 days)
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
Infants and toddlers (28 days-23 months)
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
235 Participants
n=41 Participants
|
215 Participants
n=1581 Participants
|
450 Participants
n=4626 Participants
|
|
Age, Customized
Adults (18-64 years)
|
265 Participants
n=41 Participants
|
285 Participants
n=1581 Participants
|
550 Participants
n=4626 Participants
|
|
Age, Customized
From 65-84 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
266 Participants
n=41 Participants
|
272 Participants
n=1581 Participants
|
538 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=41 Participants
|
228 Participants
n=1581 Participants
|
462 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=41 Participants
|
79 Participants
n=1581 Participants
|
147 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
423 Participants
n=41 Participants
|
417 Participants
n=1581 Participants
|
840 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
13 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
320 Participants
n=41 Participants
|
334 Participants
n=1581 Participants
|
654 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
132 Participants
n=41 Participants
|
108 Participants
n=1581 Participants
|
240 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=41 Participants
|
14 Participants
n=1581 Participants
|
33 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
21 Participants
n=41 Participants
|
30 Participants
n=1581 Participants
|
51 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
10 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Day 4 and Day 32Population: 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.
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.
Outcome measures
| Measure |
Sequence 1 (mRNA-1273.712 - Placebo): Placebo
n=910 Participants
Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): Placebo
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712
Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.
|
Sequence 1 (mRNA-1273.712 - Placebo): mRNA-1273.712
n=890 Participants
Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.
|
|---|---|---|---|---|
|
Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
|
0 Participants
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-injection 1: Day 1Population: 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.
Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females.
Outcome measures
| Measure |
Sequence 1 (mRNA-1273.712 - Placebo): Placebo
n=489 Participants
Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): Placebo
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712
Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.
|
Sequence 1 (mRNA-1273.712 - Placebo): mRNA-1273.712
n=491 Participants
Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.
|
|---|---|---|---|---|
|
Number of Participants With Elevated cTnI Level at Day 1 (Baseline)
|
5 Participants
|
—
|
—
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 29 and Day 57Population: 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.
Elevated cTnI was defined as \>53.53 pg/mL in males and \>38.64 pg/mL in females.
Outcome measures
| Measure |
Sequence 1 (mRNA-1273.712 - Placebo): Placebo
n=853 Participants
Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): Placebo
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712
Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.
|
Sequence 1 (mRNA-1273.712 - Placebo): mRNA-1273.712
n=858 Participants
Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.
|
|---|---|---|---|---|
|
Number of Participants With Elevated cTnI Level at Day 29 or Day 57 (28 Days After Injection 1 or Injection 2)
|
8 Participants
|
—
|
—
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 57Population: Safety Set: All randomized participants who received at least 1 study injection. Data were collected and presented by study intervention sequence, and treatment received.
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.
Outcome measures
| Measure |
Sequence 1 (mRNA-1273.712 - Placebo): Placebo
n=460 Participants
Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): Placebo
n=497 Participants
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.
|
Sequence 2 (Placebo - mRNA-1273.712): mRNA-1273.712
n=454 Participants
Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.
|
Sequence 1 (mRNA-1273.712 - Placebo): mRNA-1273.712
n=500 Participants
Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.
|
|---|---|---|---|---|
|
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
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
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
MAAEs
|
5 Participants
|
9 Participants
|
10 Participants
|
6 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
AESIs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 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
AEs Leading to Study Discontinuation
|
0 Participants
|
1 Participants
|
0 Participants
|
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
AEs Leading to Discontinuation of Study Injection
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
mRNA-1273.712 - Placebo Sequence: mRNA-1273.712
mRNA-1273.712 - Placebo Sequence: Placebo
Placebo - mRNA-1273.712 Sequence: Placebo
Placebo - mRNA-1273.712: mRNA-1273.712
Serious adverse events
| Measure |
mRNA-1273.712 - Placebo Sequence: mRNA-1273.712
n=500 participants at risk
Participants received mRNA-1273.712 as an IM injection on Day 1 in Sequence 1 of the study.
|
mRNA-1273.712 - Placebo Sequence: Placebo
n=460 participants at risk
Participants received placebo matching mRNA-1273.712 as an IM injection on Day 29 in Sequence 1 of the study.
|
Placebo - mRNA-1273.712 Sequence: Placebo
n=497 participants at risk
Participants received placebo matched to mRNA-1273.712 as an IM injection on Day 1 in Sequence 2 of the study.
|
Placebo - mRNA-1273.712: mRNA-1273.712
n=454 participants at risk
Participants received mRNA-1273.712 as an IM injection on Day 29 in Sequence 2 of the study.
|
|---|---|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/500 • Day 1 up to Day 57
Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
|
0.00%
0/460 • Day 1 up to Day 57
Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
|
0.00%
0/497 • Day 1 up to Day 57
Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
|
0.22%
1/454 • Number of events 1 • Day 1 up to Day 57
Safety Set: All randomized participants who received at least 1 dose of study injection. Data are presented by study intervention sequence, and treatment received.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place