A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
NCT05827926 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1758
Last updated 2025-12-23
Summary
The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.
The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.
Conditions
Interventions
- BIOLOGICAL
-
Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
- BIOLOGICAL
-
mRNA-1083.1
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1083.2
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1083.3
Sterile liquid for injection
- BIOLOGICAL
-
Investigational Influenza Vaccine 1
Sterile liquid for injection
- BIOLOGICAL
-
Investigational COVID-19 Vaccine 1
Sterile liquid for injection
- BIOLOGICAL
-
COVID-19 Vaccine 1
Sterile liquid for injection
- BIOLOGICAL
-
Investigational Influenza Vaccine 2
Sterile liquid for injection
- BIOLOGICAL
-
Influenza Vaccine 2
quadrivalent seasonal influenza vaccine
- BIOLOGICAL
-
Sterile liquid for injection
- BIOLOGICAL
-
Investigational COVID-19 Vaccine 2
Sterile liquid for injection
- BIOLOGICAL
-
COVID-19 Vaccine 2
Sterile liquid for injection
Sponsors & Collaborators
-
ModernaTX, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-04-14
- Primary Completion
- 2024-12-03
- Completion
- 2024-12-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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