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

Last updated: October 8, 2024
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

N/A

Treatment

Quadrivalent Influenza mRNA Vaccine MRT5429

Quadrivalent Influenza mRNA Vaccine MRT5424

Quadrivalent Influenza mRNA Vaccine MRT5421

Clinical Study ID

NCT06361875
VAV00045
U1111-1295-2852
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria: - Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries.

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding and one of the following conditions applies:

  • Is of non-childbearing potential. To be considered of non-childbearingpotential, a female must be postmenopausal for at least 1 year, or surgicallysterile OR

  • Is of childbearing potential and agrees to use an effective contraceptivemethod or abstinence from at least 4 weeks prior to study interventionadministration until at least 12 weeks after study intervention administration.

  • A female participant of childbearing potential must have a negative highly sensitivepregnancy test (urine or serum as required by local regulation) within 8 hours

Exclusion

before the 1st dose of study intervention Exclusion Criteria: Participants areexcluded from the study if any of the following criteria apply:

  • Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 3months)

  • Known systemic hypersensitivity to any of the study intervention components (eg,polyethylene glycol, polysorbate); history of a life-threatening reaction to thestudy interventions used in the study or to a product containing any of the samesubstances; any allergic reaction (eg, anaphylaxis) after administration of mRNAvaccine

  • 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, andvasculitis

  • Participants with an ECG that is consistent with possible myocarditis orpericarditis or, in the opinion of the investigator, demonstrates clinicallyrelevant abnormalities that may affect participant safety or study results

  • Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based onInvestigator'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 itmight 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. Aprospective participant should not be included in the study until the condition hasresolved or the febrile event has subsided

  • Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR orantigen test in the past 10 days prior to the 1st visit (V01)

  • Receipt of any vaccine in the 4 weeks preceding study intervention administration orplanned receipt of any vaccine in the 4 weeks following study interventionadministration

  • Receipt of immune globulins, blood or blood-derived products in the past 3 months

  • Previous vaccination against influenza in the previous 6 months with aninvestigational or marketed vaccine

  • Receipt of any mRNA vaccine/product in the 2 months preceding study interventionadministration NOTE: The above information is not intended to contain allconsiderations relevant to a patient's potential participation in a clinical trial.

Study Design

Total Participants: 910
Treatment Group(s): 6
Primary Treatment: Quadrivalent Influenza mRNA Vaccine MRT5429
Phase: 1/2
Study Start date:
April 01, 2024
Estimated Completion Date:
May 22, 2025

Study Description

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

Connect with a study center

  • Investigational Site Number : 3400001

    San Pedro Sula, 21104
    Honduras

    Site Not Available

  • Investigational Site Number : 6300002

    Barrio Sabana, 00694
    Puerto Rico

    Site Not Available

  • Coastal Clinical Research, Inc. Site Number : 8400050

    Mobile, Alabama 36608
    United States

    Site Not Available

  • Alliance for Multispecialty Research- Phoenix Site Number : 8400035

    Tempe, Arizona 85281
    United States

    Site Not Available

  • Smart Cures Clinical Research Site Number : 8400044

    Anaheim, California 92806
    United States

    Site Not Available

  • Velocity Clinical Research Site Number : 8400048

    La Mesa, California 91942
    United States

    Site Not Available

  • Long Beach Clinical Trials Site Number : 8400013

    Long Beach, California 90806
    United States

    Site Not Available

  • California Research Foundation Site Number : 8400038

    San Diego, California 92123-1881
    United States

    Site Not Available

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

    DeLand, Florida 32720-0834
    United States

    Site Not Available

  • SIMEDHealth, LLC Site Number : 8400011

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Indago Research and Health Center Site Number : 8400032

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Cenexel Research Centers of America Site Number : 8400037

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Research Centers of America Site Number : 8400037

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Clinical Site Partners Site Number : 8400058

    Leesburg, Florida 34748
    United States

    Site Not Available

  • Suncoast Research Group, LLC Site Number : 8400015

    Miami, Florida 33135
    United States

    Site Not Available

  • Great Lakes Clinical Trials Site Number : 8400059

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Brengle Family Medicine Site Number : 8400045

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • AMR El Dorado Site Number : 8400041

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • AMR Wichita East Site Number : 8400039

    Wichita, Kansas 67207
    United States

    Site Not Available

  • AMR Lexington Site Number : 8400042

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Velocity Clinical Research Site Number : 8400053

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • AMR New Orleans Site Number : 8400040

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Velocity Clinical Research- New Orleans Site Number : 8400053

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Optimal Research, LLC Rockville Site Number : 8400025

    Rockville, Maryland 20850
    United States

    Site Not Available

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

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Sundance Clinical Research, LLC Site Number : 8400012

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Velocity Clinical Research Norfolk Site Number : 8400046

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Velocity Clinical Research, Omaha Site Number : 8400008

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Rochester Clinical Research. Inc. Site Number : 8400005

    Rochester, New York 14609
    United States

    Site Not Available

  • Aventiv Research Columbus Site Number : 8400020

    Columbus, Ohio 43213
    United States

    Site Not Available

  • AMR Norman Site Number : 8400054

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Coastal Carolina Research Center Site Number : 8400014

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • WR-ClinSearch, LLC Site Number : 8400028

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • AMR Knoxville Site Number : 8400043

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Elligo Health Research, Inc. Site Number : 8400049

    Austin, Texas 78704
    United States

    Site Not Available

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

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056

    Tomball, Texas 77375
    United States

    Site Not Available

  • Cenexel JBR Site Number : 8400051

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • JBR Clinical Research Site Number : 8400051

    Salt Lake City, Utah 84107
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.