NCT06097273

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,061 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).

Conditions

• SARS-CoV-2
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1083	Suspension for injection
BIOLOGICAL	Placebo	0.9% sodium chloride suspension for injection
BIOLOGICAL	Influenza Vaccine	Commercially available formulation (Suspension for injection \[pre-filled syringe\])
BIOLOGICAL	COVID-19 Vaccine	Commercially available formulation (Suspension for injection)

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-05-28
• Completion: 2024-05-28
• First posted: 2023-10-24
• Last updated: 2025-07-01
• Results posted: 2025-06-13

Locations

146 sites across 1 country: United States

Regulatory

• FDA-regulated drug study