NCT06864143

A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,320 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.

Conditions

• Influenza
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1083 Composition 1 Dose A Lot A	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 1 Dose A Lot B	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 1 Dose B	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 1 Dose C	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 2 Dose A	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 2 Dose B	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 3 Dose A	Sterile liquid for injection
BIOLOGICAL	mRNA-1083 Composition 3 Dose B	Sterile liquid for injection
BIOLOGICAL	Influenza Vaccine	Sterile liquid for injection
BIOLOGICAL	COVID-19 Vaccine	Sterile liquid for injection
BIOLOGICAL	Investigational Influenza Vaccine	Sterile liquid for injection
BIOLOGICAL	Investigational COVID-19 Vaccine Lot A	Sterile liquid for injection
BIOLOGICAL	Investigational COVID-19 Vaccine Lot B	Sterile liquid for injection

Timeline

• Start date: 2025-03-07
• Primary completion: 2025-10-13
• Completion: 2025-10-13
• First posted: 2025-03-07
• Last updated: 2025-10-20

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study