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NCT05330975 · ClinicalTrials.gov registry record · Phase 3
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
A Phase 3 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,317
- Enrollment target
NCT05330975 is a Phase 3 study that has completed, run by ModernaTX. The registered enrollment target is 3,317 participants.
The verdict
NCT05330975, a Phase 3 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,317 participants
- Enrollment target
Study Summary
The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1345
- BIOLOGICAL Afluria® Quadrivalent
- BIOLOGICAL mRNA-1273.214
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,317 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05330975
The ClinicalTrials.gov registry entry for NCT05330975 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,317 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 4 interventions - of which Placebo is the first listed.
NCT05330975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05330975 about?
NCT05330975 is a clinical study titled "A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age". The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate th...
What is the current status of trial NCT05330975?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,317 participants. The study started on 2022-04-01. Estimated completion is 2024-11-08.
What interventions are being tested in trial NCT05330975?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL), Afluria® Quadrivalent (BIOLOGICAL), mRNA-1273.214 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05330975?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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