A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older

Last updated: April 2, 2025
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Recruiting

Phase

1/2

Condition

Influenza

Healthy Volunteers

Treatment

Quadrivalent Influenza Standard Dose Vaccine

Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1

Quadrivalent Influenza Vaccine High Dose

Clinical Study ID

NCT06744205
FBP00021
U1111-1303-3537
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant aged 50 years on the day of inclusion

  • 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 contraceptive method orabstinence from at least 4 weeks prior to study intervention administration until atleast 12 weeks after study intervention administration.

A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention.

Exclusion

Exclusion Criteria:

Participants are not eligible for the study if any of the following criteria are met:

  • 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 Guillain-Barré syndrome, neuritis (includingBell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis

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

  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccinationbased on Investigator's judgment

  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating IM 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 judgement)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.

  • Alcohol, prescription drug, or substance abuse that, in the opinion of theInvestigator, might interfere with the study conduct or completion

  • Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR orantigen test in the past 10 days prior to the first 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 or planned receipt of any mRNA vaccine in the 2 months after studyvaccination

  • Participation at the time of study enrollment (or in the 4 weeks preceding studyintervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure

  • Self-reported or documented seropositivity for human immunodeficiency virus,hepatitis B virus, or hepatitis C virus

Study Design

Total Participants: 1158
Treatment Group(s): 5
Primary Treatment: Quadrivalent Influenza Standard Dose Vaccine
Phase: 1/2
Study Start date:
January 06, 2025
Estimated Completion Date:
May 01, 2026

Study Description

Study details include the following:

  • Study Duration: approximately 12 months for each participant

  • Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control

  • Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call)

  • Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort

Connect with a study center

  • Investigational Site Number : 0360001

    Botany, New South Wales 2019
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360003

    Bayswater, Victoria 3153
    Australia

    Active - Recruiting

  • Investigational Site Number : 0360002

    Melbourne, Victoria 3124
    Australia

    Active - Recruiting

  • Accel Research Sites Network - Birmingham- Site Number : 8400008

    Birmingham, Alabama 35216
    United States

    Active - Recruiting

  • AMR Mobile- Site Number : 8400022

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015

    Tempe, Arizona 85281
    United States

    Active - Recruiting

  • AMR Miami- Site Number : 8400021

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Accel Research Sites - Maitland- Site Number : 8400007

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011

    Palmetto Bay, Florida 33157
    United States

    Active - Recruiting

  • Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001

    Decatur, Georgia 30030-2627
    United States

    Active - Recruiting

  • AMR - Chicago- Site Number : 8400012

    Oak Brook, Illinois 60532
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Newton- Site Number : 8400020

    Newton, Kansas 67114
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Wichita East- Site Number : 8400014

    Wichita, Kansas 67207
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Lexington- Site Number : 8400018

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Boston Clinical Trials- Site Number : 8400009

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • ActivMed Practices & Research - Methuen- Site Number : 8400005

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • Quest Research Institute- Site Number : 8400010

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Kansas City- Site Number : 8400019

    Kansas City, Missouri 64114
    United States

    Active - Recruiting

  • AMR Las Vegas - Site Number : 8400016

    Las Vegas, Nevada 89119
    United States

    Active - Recruiting

  • Coastal Carolina Research Center - North Charleston- Site Number : 8400002

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Alliance for Multispeciality Research - Knoxville- Site Number : 8400017

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Charlottesville Medical Research- Site Number : 8400004

    Charlottesville, Virginia 22911
    United States

    Active - Recruiting

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