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NCT05375838 · ClinicalTrials.gov registry record · Phase 1
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 550
- Enrollment target
NCT05375838: Completed Phase 1 study, sponsored by ModernaTX.
NCT05375838 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 550 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (817% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05375838, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 550 participants
- Enrollment target
Study Summary
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
Primary Outcome
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, th
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1273
- BIOLOGICAL mRNA-1010
- BIOLOGICAL mRNA-1073
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 550 participants |
| Start Date | 2022-05-13 |
| Est. Completion | 2022-12-29 |
| Phase | Phase 1 |
What the finished NCT05375838 record still lists
NCT05375838 is an interventional study that assigns participants to a tested intervention. The registered 550 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (817% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05375838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05375838 about?
NCT05375838 is a clinical study titled "A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old". The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
What is the current status of trial NCT05375838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 550 participants. The study started on 2022-05-13. Estimated completion is 2022-12-29.
What interventions are being tested in trial NCT05375838?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1273 (BIOLOGICAL), mRNA-1010 (BIOLOGICAL), mRNA-1073 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05375838?
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 NCT05375838's enrollment target sits among peer trials
550 35th of 2000 higher than 1,966 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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