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NCT06634797 · ClinicalTrials.gov registry record · Phase 4
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
A Phase 4 study of Healthy Volunteers, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT06634797: Completed Phase 4 study of Healthy Volunteers, sponsored by ModernaTX.
NCT06634797 is a Phase 4 study of Healthy Volunteers that has completed, run by ModernaTX. The registered enrollment target is 1,000 participants, above the 478-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06634797, a Phase 4 study of Healthy Volunteers, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1273.712
Study Locations (20)
California
- Velocity Clinical Research, Huntington Park - Huntington Park
- Velocity Clinical Research, San Diego - La Mesa
- Velocity Clinical Research, Banning - San Bernardino
Louisiana
- Velocity Clinical Research, Covington - Covington
- Velocity Clinical Research, Lafayette - Lafayette
- Velocity Clinical Research, New Orleans - New Orleans
Nebraska
- Velocity Clinical Research, Grand Island - Grand Island
- Velocity Clinical Research, Lincoln - Lincoln
- Velocity Clinical Research, Omaha - Omaha
Ohio
- Velocity Clinical Research, Cleveland - Beachwood
- Velocity Clinical Research, Cincinnati, Blue Ash - Blue Ash
Arizona
- Velocity Clinical Research, Phoenix - Phoenix
District of Columbia
- Velocity Clinical Research, Washington DC - Washington D.C.
Georgia
- Velocity Clinical Research, Savannah - Savannah
Idaho
- Velocity Clinical Research, Boise - Meridian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-10-08 |
| Est. Completion | 2025-01-20 |
| Phase | Phase 4 |
What the finished NCT06634797 record still lists
NCT06634797 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 478-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (109% higher).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06634797 names 20 study sites across 13 states, led by California, Louisiana, Nebraska.
Frequently Asked Questions
What is clinical trial NCT06634797 about?
NCT06634797 is a clinical study titled "A Study to Investigate 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.
What is the current status of trial NCT06634797?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,000 participants. The study started on 2024-10-08. Estimated completion is 2025-01-20.
What conditions does trial NCT06634797 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06634797?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1273.712 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06634797?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06634797 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06634797's enrollment target sits among peer trials
1,000 14th of 283 higher than 265 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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