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NCT05868382 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
A Phase 2 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 270
- Enrollment target
NCT05868382: Completed Phase 2 study, sponsored by ModernaTX.
NCT05868382 is a Phase 2 study that has completed, run by ModernaTX. The registered enrollment target is 270 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05868382, a Phase 2 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 270 participants
- Enrollment target
Study Summary
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
Primary Outcome
Solicited ARs (local and systemic) were collected in an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Hea
Interventions
- BIOLOGICAL mRNA-1010
- BIOLOGICAL mRNA-1010.4
- BIOLOGICAL mRNA-1010.6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2023-05-15 |
| Est. Completion | 2023-12-19 |
| Phase | Phase 2 |
What the finished NCT05868382 record still lists
NCT05868382 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 3 interventions - of which mRNA-1010 is the first listed.
NCT05868382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05868382 about?
NCT05868382 is a clinical study titled "Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults". The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
What is the current status of trial NCT05868382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 270 participants. The study started on 2023-05-15. Estimated completion is 2023-12-19.
What interventions are being tested in trial NCT05868382?
The interventions under investigation include: mRNA-1010 (BIOLOGICAL), mRNA-1010.4 (BIOLOGICAL), mRNA-1010.6 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05868382?
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 NCT05868382's enrollment target sits among peer trials
270 205th of 2000 higher than 1,793 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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