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NCT06744205 | RECRUITING | Influenza

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

Sanofi Pasteur, a Sanofi Company

Brief 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.

Condition or disease

Influenza

Healthy Volunteers

Intervention/treatment

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

TIV mRNA-neuraminidase (NA)

TIV mRNA-HA Vaccine 2

Quadrivalent Influenza Standard Dose Vaccine

Quadrivalent Influenza Vaccine High Dose

Phase

PHASE1

PHASE2

Detailed 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

Study Type : INTERVENTIONAL
Estimated Enrollment : 1158 participants
Masking : QUADRUPLE
Masking Description : Modified double-blind (participants; sites, except for those preparing/administering study intervention; and Sponsor will be blinded. Sponsor's internal safety monitoring team could be unblinded if necessary)
Primary Purpose : PREVENTION
Official Title : A Phase I/II, Randomized, Modified Double-blind Study to Investigate the Safety and Immunogenicity of Different Doses of Hexavalent Influenza mRNA HA + mRNA NA Vaccine in Adult Participants 50 Years of Age and Older
Actual Study Start Date : 2025-01-06
Estimated Primary Completion Date : 2026-05-01
Estimated Study Completion Date : 2026-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Participant aged 50 years on the day of inclusion
  • * 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.
    • 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 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 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 Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
      • * Participants with an electrocardiogram 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 (IM) vaccination based 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 it might 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
      • * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
      • * Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first 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 or planned receipt of any mRNA vaccine in the 2 months after study vaccination
      • * Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
      • * Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older

Location Details

NCT06744205

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

Accel Research Sites Network - Birmingham- Site Number : 8400008

Birmingham, Albama, United States, 35216

RECRUITING

United States, Albama

AMR Mobile- Site Number : 8400022

Mobile, Albama, United States, 36608

RECRUITING

United States, Arizona

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

Tempe, Arizona, United States, 85281

RECRUITING

United States, Florida

AMR Miami- Site Number : 8400021

Coral Gables, Florida, United States, 33134

RECRUITING

United States, Florida

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

DeLand, Florida, United States, 32720

RECRUITING

United States, Florida

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

Fort Myers, Florida, United States, 33912

RECRUITING

United States, Florida

Accel Research Sites - Maitland- Site Number : 8400007

Maitland, Florida, United States, 32751

RECRUITING

United States, Florida

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

Palmetto Bay, Florida, United States, 33157

RECRUITING

United States, Georgia

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

Decatur, Georgia, United States, 30030-2627

RECRUITING

United States, Illinois

AMR - Chicago- Site Number : 8400012

Oak Brook, Illinois, United States, 60532

RECRUITING

United States, Kansas

Alliance for Multispeciality Research - Newton- Site Number : 8400020

Newton, Kansas, United States, 67114

RECRUITING

United States, Kansas

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

Wichita, Kansas, United States, 67207

RECRUITING

United States, Kentucky

Alliance for Multispeciality Research - Lexington- Site Number : 8400018

Lexington, Kentucky, United States, 40509

RECRUITING

United States, Massachusetts

Boston Clinical Trials- Site Number : 8400009

Boston, Massachusetts, United States, 02131

RECRUITING

United States, Massachusetts

ActivMed Practices & Research - Methuen- Site Number : 8400005

Methuen, Massachusetts, United States, 01844

RECRUITING

United States, Road cancer

Quest Research Institute- Site Number : 8400010

Farmington Hills, Road cancer, United States, 48334

RECRUITING

United States, Missouri

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

Kansas City, Missouri, United States, 64114

RECRUITING

United States, Nevada

AMR Las Vegas - Site Number : 8400016

Las Vegas, Nevada, United States, 89119

RECRUITING

United States, South Carolina

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

North Charleston, South Carolina, United States, 29405

RECRUITING

United States, Tennessee

Alliance for Multispeciality Research - Knoxville- Site Number : 8400017

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Virginia

Charlottesville Medical Research- Site Number : 8400004

Charlottesville, Virginia, United States, 22911

RECRUITING

Australia, New South Wales

Investigational Site Number : 0360001

Botany, New South Wales, Australia, 2019

RECRUITING

Australia, Victoria

Investigational Site Number : 0360003

Bayswater, Victoria, Australia, 3153

RECRUITING

Australia, Victoria

Investigational Site Number : 0360002

Melbourne, Victoria, Australia, 3124