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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

NCT06694389 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2457

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

SARS-CoV-2 Vaccine

Suspension for injection

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)

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-11-17
Completion
2025-11-17
FDA Drug
Yes

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06694389 on ClinicalTrials.gov