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AzTrials

Influenza ImmunizationPhase 1/2NCT05650554

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

A Phase 1/2 study testing Quadrivalent Influenza mRNA Vaccine MRT5413, Quadrivalent Recombinant Influenza Vaccine and Quadrivalent Influenza Standard Dose Vaccine in people with Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 35 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza Immunization
What is being tested?
Quadrivalent Influenza mRNA Vaccine MRT5413, Quadrivalent Recombinant Influenza Vaccine and Quadrivalent Influenza Standard Dose Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
682 participants
Where
35 sitesin 3 countries
Study dates
12 Dec 2022to 2 Apr 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
  • 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.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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)
  • Previous history of myocarditis, pericarditis, and / or myopericarditis
  • 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
  • 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
  • Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  • NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

35 sites in 3 countries.

35 sites in 3 countries

United States28 sites

  • Elligo Health Research, Inc. Site Number : 8400002

    Austin, Texas, 78704

  • ClinSearch Site Number : 8400013

    Chattanooga, Tennessee, 37421

  • Velocity Clinical Research-Chula Vista Site Number : 8400061

    Chula Vista, California, 91911

  • Velocity Clinical Research Site Number : 8400001

    Cleveland, Ohio, 44122

  • Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032

    DeLand, Florida, 32720-0834

  • Velocity Clinical Research - Providence Site Number : 8400019

    East Greenwich, Rhode Island, 02818

  • Velocity New Smyrna Beach Site Number : 8400063

    Edgewater, Florida, 32132

  • SIMEDHealth, LLC Site Number : 8400014

    Gainesville, Florida, 32607

  • Velocity Gardena Site Number : 8400062

    Gardena, California, 90247

  • Indago Research and Health Center Site Number : 8400044

    Hialeah, Florida, 33012

  • Cenexel Research Centers of America Site Number : 8400011

    Hollywood, Florida, 33024

  • DM Clinical Research- Bellaire Site Number : 8400026

    Houston, Texas, 77081

  • Brengle Family Medicine Site Number : 8400039

    Indianapolis, Indiana, 46260

  • Velocity Clinical Research Lincoln Site Number : 8400049

    Lincoln, Nebraska, 68510

  • Long Beach Clinical Trials Site Number : 8400052

    Long Beach, California, 90806

  • Velocity Clinical Research Site Number : 8400024

    Meridian, Idaho, 83642

  • Florida International Research Center Site Number : 8400045

    Miami, Florida, 33173

  • Suncoast Research Associates, LLC Site Number : 8400060

    Miami, Florida, 33173

  • Meridian Clinical Research Site Number : 8400017

    Norfolk, Nebraska, 68701

  • Coastal Carolina Research Center Site Number : 8400042

    North Charleston, South Carolina, 29405

  • Velocity Clinical Research, North Hollywood Site Number : 8400051

    North Hollywood, California, 91606

  • Velocity Clinical Research Site Number : 8400008

    Omaha, Nebraska, 68134

  • DM Clinical Research - Chicago Site Number : 8400025

    River Forest, Illinois, 60305

  • Rochester Clinical Research. Inc. Site Number : 8400027

    Rochester, New York, 14609

  • Clinical Trials of Texas, Inc. - PPDS Site Number : 8400016

    San Antonio, Texas, 78229

  • California Research Foundation Site Number : 8400006

    San Diego, California, 92123-1881

  • Meridian Clinical Research Site Number : 8400022

    Savannah, Georgia, 31406

  • Florida Pulmonary Research Center Site Number : 8400036

    Winter Park, Florida, 32789

Other trials in United States

Australia5 sites

  • Investigational Site Number : 0360004

    Darlinghurst, New South Wales, 2010

  • Investigational Site Number : 0360005

    Kanwal, New South Wales, 2259

  • Investigational Site Number : 0360003

    Maroubra, New South Wales, 2035

  • Investigational Site Number : 0360001

    Morayfield, Queensland, 4506

  • Investigational Site Number : 0360002

    North Melbourne, Victoria, 3051

Other trials in Australia

Puerto Rico2 sites

  • Investigational Site Number : 6300001

    Barrio Sabana, 00694

  • Investigational Site Number : 6300002

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adults Aged 18 Years and Older

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.

Read the detailed description

Study duration is approximately 12 months.

Being tested
Quadrivalent Influenza mRNA Vaccine MRT5413, Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Influenza Standard Dose Vaccine, Quadrivalent Influenza High-Dose Vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent Influenza mRNA Vaccine MRT5413Biological

    Pharmaceutical Form: Liquid frozen solution in a vial

    Route of Administration: Intramuscular injection

  • Quadrivalent Recombinant Influenza VaccineBiological

    Also called Flublok Quadrivalent®

    Pharmaceutical Form: Liquid frozen solution in a vial

    Route of Administration: Intramuscular injection

  • Quadrivalent Influenza Standard Dose VaccineBiological

    Also called Fluzone Qudrivalent®

    Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe

    Route of Administration: Intramuscular injection

  • Quadrivalent Influenza High-Dose VaccineBiological

    Also called Fluzone High-Dose Quadrivalent®

    Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe

    Route of Administration: Intramuscular injection

Study groups in NCT05650554
Study groupRoleWhat they receive
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low doseExperimentalparticipants will receive a single dose of QIV mRNA vaccine (low dose)
Receives: Biological: Quadrivalent Influenza mRNA Vaccine MRT5413
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium doseExperimentalparticipants will receive a single dose of QIV mRNA vaccine (medium dose)
Receives: Biological: Quadrivalent Influenza mRNA Vaccine MRT5413
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high doseExperimentalparticipants will receive a single dose of QIV mRNA vaccine (high dose)
Receives: Biological: Quadrivalent Influenza mRNA Vaccine MRT5413
Group 4: RIV4Active comparatorparticipants will receive a single dose of RIV4 vaccine
Receives: Biological: Quadrivalent Recombinant Influenza Vaccine
Group 5: QIV-SDActive comparatorparticipants will receive a single dose of QIV-SD vaccine
Receives: Biological: Quadrivalent Influenza Standard Dose Vaccine
Group 6: QIV-HDActive comparatorparticipants will receive a single dose of QIV -HD vaccine (for elderly only)
Receives: Biological: Quadrivalent Influenza High-Dose Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with immediate adverse events (AEs)

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

    Measured: Within 30 minutes after injection

  2. Number of participants with solicited injection site or systemic reactions

    Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, redness, swelling, hardening, bruising Systemic reactions: fever, headache, malaise, myalgia, arthralgia, chills

    Measured: Up to 7 days after injection

  3. Number of participants with unsolicited AEs

    AEs that do not fulfill the conditions of solicited reactions

    Measured: Up to 28 days after injection

  4. Number of participants with medically attended adverse events (MAAE)s

    AEs with a new onset or a worsening of a condition that prompts the participant or participant to seek unplanned medical advice at a physician's office or Emergency Department

    Measured: Up to 180 days after injection

  5. Number of participants with serious adverse events (SAEs)

    SAEs reported throughout the study

    Measured: From Day one to Day 366

  6. Number of participants with out-of-range biological test results

    Out-of-range biological test results (including shift from baseline values)

    Measured: Up to 8 days after injection

  7. Individual Hemagglutination inhibition (HAI) titer

    Antibody titers are expressed as GMTs at baseline and post-baseline

    Measured: At Day 1 and Day 29

  8. Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]

    Measured: At Day 1 and Day 29

  9. Individual HAI titer ratio

    Ratios of antibody titers measured by HAI in each group before and after vaccination

    Measured: At Day 1 and Day 29

  10. Number of participants archiving HAI seroconversion against Antigens

    Number of participants with titer < 10 [1/dil] at Day 1 and post-vaccination titer ≥ 40 [1/dil] at Day 29, or titer ≥ 10 [1/dil] at Day 1 and a ≥ 4-fold-rise in titer [1/dil] at Day 29

    Measured: At Day 1 and Day 29

  11. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

    Measured: At Day 29

  12. Percentage of participants with 2-fold and 4-fold rise in HAI titers

    Measured: At Day 1 and Day 29

Secondary outcomes (6)

  1. Neutralizing Ab titers

    Neutralizing Ab titers expressed as GMTs

    Measured: At Day 1 and Day 29

  2. Individual neutralizing antibodies titer ratio

    Measured: At Day 1 and Day 29

  3. Percentage of participants with 2-fold and 4-fold increase in neutralizing titers

    Measured: At Day 1 and Day 29

  4. Individual HAI Ab titer ratio

    Measured: Day 1, Day 91, Day 181 and Day 366

  5. Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

    Measured: At Day 91, Day 181 and Day 366

  6. Individual antibodies HAI titer ratio

    Measured: Day 1, Day 91, Day 181 and Day 366

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start12 Dec 2022
  3. Primary completion2 Apr 2024
  4. Study completion2 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Sentinel Cohort: Open label Main Cohort: * Open label (Sponsor, except laboratory testing personnel) * Blinded (Sites, except for those preparing/administering study intervention)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650554
Sponsor's protocol ID
VAV00029
Other IDs
U1111-1279-3180
Status last verified
Mar 2025
First submitted
6 Dec 2022
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Quadrivalent Influenza mRNA Vaccine MRT5413, Quadrivalent Recombinant Influenza Vaccine and Quadrivalent Influenza Standard Dose Vaccine in people with Influenza Immunization, run by Sanofi Pasteur, a Sanofi Company at 35 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with immediate adverse events (AEs) (time frame: Within 30 minutes after injection). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05650554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.

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