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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 is a Phase 2 study that has completed, run by ModernaTX. The registered enrollment target is 36,814 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05127434
The ClinicalTrials.gov registry entry for NCT05127434 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36,814 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05127434 reports 0 study locations.
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.
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