Comparison · NCT06634797-84add0a7
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT06634797-84add0a7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06634797-84add0a7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00112 | 0.000198 | 0.00634 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0042 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00112 | -0.00318 | 0.00634 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on mRNA-1273.712 than on Placebo | 890 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | mRNA-1273.712 | Participants received mRNA-1273.712 as an IM injection on either Day 1 in Sequence 1 (mRNA-1273.712 - placebo) or Day 29 in Sequence 2 (placebo - mRNA-1273.712) of the study. | 1 | 890 | OG000 |
| Group 2 | Placebo | Participants received placebo matched to mRNA-1273.712 as an IM injection on either Day 1 in Sequence 2 (placebo - mRNA-1273.712) or Day 29 in Sequence 1 (mRNA-1273.712 - placebo) of the study. | 0 | 910 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Elevated Cardiac Troponin I (cTnI) at Day 4 or Day 32 (3 Days After Injection 1 or Injection 2)
- Description
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.
- Time frame
- Day 4 and Day 32
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
- NCT number
- NCT06634797
- Phases
- PHASE4
- Conditions
- Healthy Volunteers
- Interventions
- mRNA-1273.712, Placebo
- Lead sponsor
- ModernaTX, Inc.
- Results first posted
- 2026-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06634797?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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