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

NCT05650554 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Influenza Immunization

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-04-02
Completion
2024-04-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05650554 on ClinicalTrials.gov