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
NCT06864143 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1320
Last updated 2025-10-20
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
Interventions
- 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
-
Sterile liquid for injection
- BIOLOGICAL
-
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
Sponsors & Collaborators
-
ModernaTX, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-07
- Primary Completion
- 2025-10-13
- Completion
- 2025-10-13
- FDA Drug
- Yes
Countries
- United States
Study Locations
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