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NCT05127434 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
A Phase 2 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 2
- Development phase
- 36,814
- Enrollment target
NCT05127434: Completed Phase 2 study, sponsored by ModernaTX.
NCT05127434 is a Phase 2 study that has completed, run by ModernaTX. The registered enrollment target is 36,814 participants, above the 132-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27789% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05127434, a Phase 2 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36,814 participants
- Enrollment target
Study Summary
The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.
Interventions
- DRUG Placebo
- DRUG mRNA-1345
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36,814 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 2 |
What the finished NCT05127434 record still lists
NCT05127434 is an interventional study that assigns participants to a tested intervention. Its 36,814 participants enrollment target places it among the larger protocols in the corpus, above the 132-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27789% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05127434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05127434 about?
NCT05127434 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age". The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo fr...
What is the current status of trial NCT05127434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36,814 participants. The study started on 2021-11-17. Estimated completion is 2025-07-28.
What interventions are being tested in trial NCT05127434?
The interventions under investigation include: Placebo (DRUG), mRNA-1345 (DRUG).
Who is sponsoring clinical trial NCT05127434?
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 NCT05127434's enrollment target sits among peer trials
36,814 1st of 2000 higher than 2,000 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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