NCT06361875

A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above

A Phase I/II Study to Investigate the Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccines MRT5421, MRT5424, and MRT5429 in Healthy Participants Aged 18 Years and Above

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 910 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) 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.

Detailed description

Study duration per participant is approximately 12 months. * Treatment duration: 1 injection of one of the 7 QIV mRNA or one of the controls * Dose escalation with sequential enrollment

Conditions

• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza mRNA Vaccine MRT5421	Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza mRNA Vaccine MRT5424	Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza mRNA Vaccine MRT5429	Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection
BIOLOGICAL	Quadrivalent Influenza Standard Dose Vaccine	Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza High-Dose Vaccine	Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection
BIOLOGICAL	Quadrivalent Recombinant Influenza Vaccine	Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-06-09
• Completion: 2025-06-09
• First posted: 2024-04-12
• Last updated: 2025-06-19

Locations

20 sites across 3 countries: United States, Honduras, Puerto Rico

Regulatory

• FDA-regulated drug study