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NCT06060457 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age
A Phase 3 study, sponsored by ModernaTX.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,900
- Enrollment target
NCT06060457: Completed Phase 3 study, sponsored by ModernaTX.
NCT06060457 is a Phase 3 study that has completed, run by ModernaTX. The registered enrollment target is 1,900 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (146% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06060457, a Phase 3 study, has completed, sponsored by ModernaTX.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,900 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.
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 Fluzone HD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,900 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2024-06-07 |
| Phase | Phase 3 |
What the finished NCT06060457 record still lists
NCT06060457 is an interventional study that assigns participants to a tested intervention. Its 1,900 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 (146% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06060457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06060457 about?
NCT06060457 is a clinical study titled "A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age". The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mR...
What is the current status of trial NCT06060457?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,900 participants. The study started on 2023-09-25. Estimated completion is 2024-06-07.
What interventions are being tested in trial NCT06060457?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL), Fluzone HD (BIOLOGICAL).
Who is sponsoring clinical trial NCT06060457?
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 NCT06060457's enrollment target sits among peer trials
1,900 110th of 2000 higher than 1,888 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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