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NCT04528719 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
A Phase 1 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 1
- Development phase
- 651
- Enrollment target
NCT04528719: Completed Phase 1 study, sponsored by ModernaTX.
NCT04528719 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 651 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (985% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04528719, a Phase 1 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 651 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
Interventions
- DRUG Placebo
- BIOLOGICAL mRNA-1345
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 651 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2024-07-18 |
| Phase | Phase 1 |
What the finished NCT04528719 record still lists
NCT04528719 is an interventional study that assigns participants to a tested intervention. The registered 651 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 (985% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04528719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04528719 about?
NCT04528719 is a clinical study titled "A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive". The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1...
What is the current status of trial NCT04528719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 651 participants. The study started on 2020-09-30. Estimated completion is 2024-07-18.
What interventions are being tested in trial NCT04528719?
The interventions under investigation include: Placebo (DRUG), mRNA-1345 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04528719?
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 NCT04528719's enrollment target sits among peer trials
651 22nd of 2000 higher than 1,979 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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