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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: Completed Phase 3 study, sponsored by ModernaTX.
NCT05330975 is a Phase 3 study that has completed, run by ModernaTX. The registered enrollment target is 3,317 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs)
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 |
What the finished NCT05330975 record still lists
NCT05330975 is an interventional study that assigns participants to a tested intervention. Its 3,317 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05330975 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05330975's enrollment target sits among peer trials
3,317 72nd of 2000 higher than 1,929 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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