NCT06060457

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, Randomized, Observer-Blind Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, When Coadministered With a High-Dose, Quadrivalent Seasonal Influenza Vaccine in Adults ≥65 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,900 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection
BIOLOGICAL	mRNA-1345	Suspension for injection
BIOLOGICAL	Fluzone HD	Suspension for injection

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-06-07
• Completion: 2024-06-07
• First posted: 2023-09-29
• Last updated: 2025-07-30
• Results posted: 2025-07-30

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study