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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 is a Phase 1 study that has completed, run by ModernaTX. The registered enrollment target is 651 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04528719
The ClinicalTrials.gov registry entry for NCT04528719 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 651 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.
NCT04528719 reports 0 study locations.
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.
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