NCT05650554

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 682 (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 up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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 is approximately 12 months.

Conditions

• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza mRNA Vaccine MRT5413	Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
BIOLOGICAL	Quadrivalent Recombinant Influenza Vaccine	Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza Standard Dose Vaccine	Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection
BIOLOGICAL	Quadrivalent Influenza High-Dose Vaccine	Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2022-12-14
• Last updated: 2025-03-19

Locations

35 sites across 3 countries: United States, Australia, Puerto Rico

Regulatory

• FDA-regulated drug study