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NCT03014089 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT03014089: Completed Phase 1 study, sponsored by ModernaTX.
NCT03014089 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03014089, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
Primary Outcome
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first s
Interventions
- OTHER Placebo
- BIOLOGICAL mRNA-1325
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2016-12-21 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
What the finished NCT03014089 record still lists
NCT03014089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03014089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03014089 about?
NCT03014089 is a clinical study titled "Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects". The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
What is the current status of trial NCT03014089?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2016-12-21. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT03014089?
The interventions under investigation include: Placebo (OTHER), mRNA-1325 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03014089?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03014089's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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