drugset / Trial / NCT05650554

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

NCT05650554

Phase 1/2 Completed 682 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2022-12-12
Primary completion
2024-04-02
Completion
2024-04-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Flublok Quadrivalent Vaccine Intramuscular
Comparator Fluzone High-Dose Quadrivalent Vaccine Intramuscular
Subject MRT5413 Messenger RNA (mRNA) Intramuscular
Comparator Quadrivalent Influenza Standard Dose Vaccine Vaccine Intramuscular

Indications

No indication recorded.