A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
NCT05972174 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1504
Last updated 2025-07-16
Summary
The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).
Conditions
Interventions
- BIOLOGICAL
-
mRNA-1018 for H5N8
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1018 for H7N9
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1018 for H5 Only
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1018 for H7 Only
Sterile liquid for injection
- BIOLOGICAL
-
mRNA-1018 for H5 Only-CG
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
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-07-10
- Primary Completion
- 2024-07-16
- Completion
- 2024-07-16
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
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