NCT05624606

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older.

Detailed description

Approximately 12 months

Conditions

• Influenza Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Influenza mRNA Vaccine MRT5410	Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent Recombinant Influenza vaccine RIV4	Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent Inactivated Influenza Standard Dose QIV-SD	Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular
BIOLOGICAL	Quadrivalent Inactivated Influenza High Dose QIV-HD	Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2022-11-22
• Last updated: 2025-03-18

Locations

25 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study