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NCT05975099 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 807
- Enrollment target
NCT05975099: Completed Phase 1 study, sponsored by ModernaTX.
NCT05975099 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 807 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1245% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05975099, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 807 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
Primary Outcome
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A summary of serious AEs (SAEs)
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1975
- BIOLOGICAL mRNA-1982
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 807 participants |
| Start Date | 2023-07-26 |
| Est. Completion | 2025-05-30 |
| Phase | Phase 1 |
What the finished NCT05975099 record still lists
NCT05975099 is an interventional study that assigns participants to a tested intervention. The registered 807 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 (1245% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05975099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05975099 about?
NCT05975099 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age". The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
What is the current status of trial NCT05975099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 807 participants. The study started on 2023-07-26. Estimated completion is 2025-05-30.
What interventions are being tested in trial NCT05975099?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1975 (BIOLOGICAL), mRNA-1982 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05975099?
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 NCT05975099's enrollment target sits among peer trials
807 12th of 2000 higher than 1,989 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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