drugset / Trial / NCT05972174

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

NCT05972174 ↗

Phase 1/2 Completed 1504 enrolled ModernaTX, Inc.
RandomizedParallel-groupTriple-blindPrevention

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).

Timeline

Start
2023-07-10
Primary completion
2024-07-16
Completion
2024-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject mRNA-1018 for H5 Only Unknown — Intramuscular
Subject mRNA-1018 for H5 Only-CG Unknown — Intramuscular
Subject mRNA-1018 for H5N8 Unknown — Intramuscular
Subject mRNA-1018 for H7 Only Unknown — Intramuscular
Subject mRNA-1018 for H7N9 Unknown — Intramuscular

Indications