MedDataX Logo

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

NCT ID: NCT06361875

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-06-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05624606

Influenza Immunization
COMPLETED PHASE1/PHASE2

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

NCT05650554

Influenza Immunization
COMPLETED PHASE1/PHASE2

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

NCT05553301

Influenza Immunization
COMPLETED PHASE1/PHASE2

Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older

NCT06118151

Influenza Influenza Immunization
COMPLETED PHASE1

Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older

NCT05426174

Influenza Immunization Healthy Volunteers
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study duration per participant is approximately 12 months.

* Treatment duration: 1 injection of one of the 7 QIV mRNA or one of the controls
* Dose escalation with sequential enrollment

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Immunization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel with dose escalation for sentinel cohort
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1

participants will receive a single dose of QIV mRNA vaccine MRT5421

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5421

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5429

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5429

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5429

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4

participants will receive a single dose of QIV mRNA vaccine MRT5429

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5429

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5424

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2

participants will receive a single dose of QIV mRNA vaccine MRT5424

Group Type EXPERIMENTAL

Quadrivalent Influenza mRNA Vaccine MRT5424

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza SD Vaccine

participants will receive a single dose of QIV-SD vaccine

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza Standard Dose Vaccine

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza HD Vaccine

participants will receive a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only)

Group Type ACTIVE_COMPARATOR

Quadrivalent Influenza High-Dose Vaccine

Intervention Type BIOLOGICAL

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

Quadrivalent Influenza RIV4 Vaccine

participants will receive a single dose of RIV4 vaccine

Group Type ACTIVE_COMPARATOR

Quadrivalent Recombinant Influenza Vaccine

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quadrivalent Influenza mRNA Vaccine MRT5421

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

Intervention Type BIOLOGICAL

Quadrivalent Influenza mRNA Vaccine MRT5424

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

Intervention Type BIOLOGICAL

Quadrivalent Influenza mRNA Vaccine MRT5429

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

Intervention Type BIOLOGICAL

Quadrivalent Influenza Standard Dose Vaccine

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

Intervention Type BIOLOGICAL

Quadrivalent Influenza High-Dose Vaccine

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

Intervention Type BIOLOGICAL

Quadrivalent Recombinant Influenza Vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fluzone Qudrivalent® Fluzone High-Dose Quadrivalent® Flublok Quadrivalent®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
* Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion Criteria

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
* Previous history of myocarditis, pericarditis, and / or myopericarditis
* Known history of previous episodes of Gillian-Barre Syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
* Participants with an ECG that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
* Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
* Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the 1st visit (V01)
* Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
* Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Long Beach Clinical Trials Site Number : 8400013

Long Beach, California, United States

Site Status

California Research Foundation Site Number : 8400038

San Diego, California, United States

Site Status

Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400001

DeLand, Florida, United States

Site Status

SIMEDHealth, LLC- Site Number : 8400011

Gainesville, Florida, United States

Site Status

Indago Research and Health Center- Site Number : 8400032

Hialeah, Florida, United States

Site Status

Cenexel Research Centers of America- Site Number : 8400037

Hollywood, Florida, United States

Site Status

Suncoast Research Group, LLC- Site Number : 8400015

Miami, Florida, United States

Site Status

Brengle Family Medicine Site Number : 8400045

Indianapolis, Indiana, United States

Site Status

AMR Lexington- Site Number : 8400042

Lexington, Kentucky, United States

Site Status

Velocity Clinical Research- New Orleans Site Number : 8400053

New Orleans, Louisiana, United States

Site Status

The Alliance for Multispecialty Research - KCM, LLC- Site Number : 8400034

Kansas City, Missouri, United States

Site Status

Velocity Clinical Research Norfolk- Site Number : 8400046

Norfolk, Nebraska, United States

Site Status

Velocity Clinical Research, Omaha- Site Number : 8400008

Omaha, Nebraska, United States

Site Status

Rochester Clinical Research. Inc.- Site Number : 8400005

Rochester, New York, United States

Site Status

Coastal Carolina Research Center- Site Number : 8400014

North Charleston, South Carolina, United States

Site Status

AMR Knoxville- Site Number : 8400043

Knoxville, Tennessee, United States

Site Status

Clinical Trials of Texas, Inc. - PPDS- Site Number : 8400029

San Antonio, Texas, United States

Site Status

Cenexel JBR- Site Number : 8400051

Salt Lake City, Utah, United States

Site Status

Investigational Site Number : 3400001

San Pedro Sula, , Honduras

Site Status

Investigational Site Number : 6300002

Barrio Sabana, , Puerto Rico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Honduras Puerto Rico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1295-2852

Identifier Type: REGISTRY

Identifier Source: secondary_id

VAV00045

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
NCT05540522 COMPLETED PHASE3
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
NCT05972174 COMPLETED PHASE1/PHASE2
A Study of Influenza Virus Vaccines in Children and Adults
NCT00988143 COMPLETED PHASE2
Study of Recombinant Influenza Vaccine Containing Different H3 Antigens Without or With Adjuvant in Healthy Adult Subjects
NCT04451954 COMPLETED PHASE1
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults
NCT01196975 COMPLETED PHASE3
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
NCT06436703 COMPLETED PHASE2
A Study of the Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Subjects Aged 65 Years and Older
NCT02553343 COMPLETED PHASE2
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
NCT05044195 COMPLETED PHASE3
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults ≥50 Years of Age
NCT05501561 COMPLETED PHASE2
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
NCT05827068 COMPLETED PHASE1/PHASE2
A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
NCT05227001 COMPLETED PHASE1
Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
NCT06907511 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens in Healthy Adult Subjects 18 to 30 Years of Age
NCT04144179 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
NCT05052697 COMPLETED PHASE1/PHASE2
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
NCT06097273 COMPLETED PHASE3
Safety and Immunogenicity of Different Formulations of an MF59-Adjuvanted Influenza Vaccine in Older Adults
NCT04782323 COMPLETED PHASE2
Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults
NCT02307851 COMPLETED PHASE2
Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Adult and Elderly Populations
NCT01746082 COMPLETED PHASE2
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above
NCT05829356 COMPLETED PHASE1
Study of Quadrivalent Influenza Vaccine Among Adults
NCT01218646 COMPLETED PHASE3
Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine
NCT05642078 COMPLETED PHASE3
A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
NCT06864143 COMPLETED PHASE2
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
NCT05596734 COMPLETED PHASE2
A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults
NCT01561768 COMPLETED PHASE2
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
NCT05446740 COMPLETED PHASE1