NCT06694389

Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,457 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).

Conditions

• COVID-19
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1083	Suspension for injection
OTHER	Placebo	0.9% sodium chloride suspension for injection
BIOLOGICAL	Licensed Influenza Vaccine	Aqueous injectable (SC) or suspension for injection (IM)
BIOLOGICAL	SARS-CoV-2 Vaccine	Suspension for injection

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2024-11-19
• Last updated: 2025-12-02

Locations

44 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study