NCT05553301

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

Completed Phase 1, PHASE2 Last updated 24 January 2025

What this trial tests

Phase 1, PHASE2 trial testing Quadrivalent Influenza mRNA Vaccine MRT5407 in Influenza Immunization in 560 participants. Completed in 19 January 2024.

Timeline

3 October 2022

Primary endpoint
19 January 2024

19 January 2024

Quick facts

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	560
Start date	3 October 2022
Primary completion	19 January 2024
Estimated completion	19 January 2024
Sites	25 locations across Puerto Rico, United States

Drugs / interventions tested

• Quadrivalent Influenza mRNA Vaccine MRT5407 — full drug profile →
• Quadrivalent Recombinant Influenza Vaccine — full drug profile →
• Quadrivalent Influenza Standard Dose Vaccine — full drug profile →
• Quadrivalent Influenza High-Dose Vaccine — full drug profile →

Conditions studied

• Influenza Immunization — all drugs for Influenza Immunization →

Sponsor

Sanofi Pasteur, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with Influenza Immunization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. mRNA vaccines for infectious diseases - advances, challenges and opportunities.
   Pardi N, Krammer F. · · 2024 · cited 111× · PMID 39367276 · DOI 10.1038/s41573-024-01042-y
2. Nanoparticle technology for mRNA: Delivery strategy, clinical application and developmental landscape.
   Li X, Qi J, Wang J, Hu W, et al · · 2024 · cited 47× · PMID 38169577 · DOI 10.7150/thno.84291
3. mRNA vaccines: a new opportunity for malaria, tuberculosis and HIV.
   Matarazzo L, Bettencourt PJG. · · 2023 · cited 35× · PMID 37168860 · DOI 10.3389/fimmu.2023.1172691
4. Recent Advances and Innovations in the Preparation and Purification of In Vitro-Transcribed-mRNA-Based Molecules.
   Zhang J, Liu Y, Li C, Xiao Q, et al · · 2023 · cited 19× · PMID 37765153 · DOI 10.3390/pharmaceutics15092182
5. mRNA Vaccines Against COVID-19 as Trailblazers for Other Human Infectious Diseases.
   Brandi R, Paganelli A, D'Amelio R, Giuliani P, et al · · 2024 · cited 10× · PMID 39772079 · DOI 10.3390/vaccines12121418
6. Brief Insights into mRNA Vaccines: Their Successful Production and Nanoformulation for Effective Response against COVID-19 and Their Potential Success for Influenza A and B.
   Parveen A, Elkordy AA. · · 2024 · cited 9× · PMID 38921798 · DOI 10.3390/pathogens13060500
7. Race with virus evolution: The development and application of mRNA vaccines against SARS-CoV-2.
   Lee KM, Lin SJ, Wu CJ, Kuo RL. · · 2023 · cited 9× · PMID 36642222 · DOI 10.1016/j.bj.2023.01.002
8. Advancing mRNA vaccines for infectious diseases: key components, innovations, and clinical progress.
   Li S, Zheng L, Zhong J, Gao X. · · 2025 · cited 8× · PMID 40321006 · DOI 10.1042/ebc20253009