NCT05972174

A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,504 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

• Influenza

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-07-16
• Completion: 2024-07-16
• First posted: 2023-08-02
• Last updated: 2025-07-16

Locations

27 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study