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

NCT05624606 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2025-03-18

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 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.

Conditions

  • Influenza Immunization

Interventions

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

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
2022-11-28
Primary Completion
2024-03-28
Completion
2024-03-28
FDA Drug
Yes

Countries

  • United States
  • 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 NCT05624606 on ClinicalTrials.gov