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A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above

NCT06361875 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2025-06-19

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 different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) compared to an active control (QIV- standard 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 MRT5421

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection

BIOLOGICAL

Quadrivalent Influenza mRNA Vaccine MRT5424

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection

BIOLOGICAL

Quadrivalent Influenza mRNA Vaccine MRT5429

Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection

BIOLOGICAL

Quadrivalent Influenza Standard Dose Vaccine

Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection

BIOLOGICAL

Quadrivalent Influenza High-Dose Vaccine

Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection

BIOLOGICAL

Quadrivalent Recombinant Influenza Vaccine

Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-06-09
Completion
2025-06-09
FDA Drug
Yes

Countries

  • United States
  • Honduras
  • 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 NCT06361875 on ClinicalTrials.gov