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
Phase 3
Completed
NCT06060457
| Condition | Respiratory Syncytial Virus |
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| Phase | Phase 3 |
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| Sponsor | ModernaTX, Inc. |
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| Status | Completed |
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| Enrollment | 1,900 participants |
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| Interventions | mRNA-1345, Fluzone HD |
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| Start date | Sep 25, 2023 |
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| Completion date | Jun 7, 2024 |
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| Results posted | Jul 30, 2025 |
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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.
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection
Within 7 days after Day 1 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 689 Participants |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 547 Participants |
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Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 22 Injection
Within 7 days after Day 22 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 251 Participants |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 557 Participants |
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Number of Participants With Unsolicited Adverse Events (AEs) Up to 21 Days After Day 1 Injection
Up to 21 days after Day 1 injection · Participants
| Fluzone HD + mRNA-1345 Followed by Placebo | 72 Participants |
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| Fluzone HD + Placebo Followed by mRNA-1345 | 72 Participants |
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Open in BENITIONS
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