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

Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD [adults ≥ 65 years of age only], or RIV4) in adults 18 years of age and older.

Study Overview

• Status: Completed
• Conditions: Influenza Immunization
• Intervention / Treatment: Biological: Quadrivalent Influenza mRNA Vaccine MRT5410; Biological: Quadrivalent Recombinant Influenza vaccine RIV4; Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD; Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD

Detailed Description

Approximately 12 months

• Study Type: Interventional
• Enrollment (Actual): 682
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • Barrio Sabana, Puerto Rico, 00694
    • Investigational Site Number : 6300002
  • San Juan, Puerto Rico, 00909
    • Investigational Site Number : 6300001
• United States
  • California
    • Huntington Park, California, United States, 90255
      • Joint Clinical Trials Huntington Park Site Number : 8400032
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials Site Number : 8400056
    • North Hollywood, California, United States, 91606
      • Velocity Clinical Research, North Hollywood Site Number : 8400063
    • San Diego, California, United States, 92123-1881
      • California Research Foundation Site Number : 8400001
  • Florida
    • Gainesville, Florida, United States, 32607
      • SIMEDHealth, LLC Site Number : 8400042
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center Site Number : 8400002
    • Hollywood, Florida, United States, 33024
      • Research Centers of America Site Number : 8400011
    • Miami, Florida, United States, 33173
      • Florida International Research Center Site Number : 8400009
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center Site Number : 8400041
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research Site Number : 8400024
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Brengle Family Medicine Site Number : 8400040
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Lexington Site Number : 8400035
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research Site Number : 8400017
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research Site Number : 8400034
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • WR-CRCN, LLC Site Number : 8400060
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center - N Charleston Site Number : 8400007
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • AMR Knoxville Site Number : 8400021
  • Texas
    • Austin, Texas, United States, 78704
      • Elligo Health Research, Inc. Site Number : 8400037
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc Site Number : 8400051
    • Humble, Texas, United States, 77338
      • DM Clinical Research Site Number : 8400046
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043
    • Sugar Land, Texas, United States, 77478
      • DM Clinical Research - Sugar Land Site Number : 8400045
    • Tomball, Texas, United States, 77375
      • Martin Diagnostic Clinic Site Number : 8400058

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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)
• Previous history of myocarditis, pericarditis, and / or myopericarditis
• Self-reported thrombocytopenia, contraindicating 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose; participants will receive a single dose (low) of QIV mRNA vaccine	Biological: Quadrivalent Influenza mRNA Vaccine MRT5410; Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Experimental: Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose; participants will receive a single dose (medium) of QIV mRNA vaccine	Biological: Quadrivalent Influenza mRNA Vaccine MRT5410; Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Experimental: Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose; participants will receive a single dose (high) of QIV mRNA vaccine	Biological: Quadrivalent Influenza mRNA Vaccine MRT5410; Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular
Active Comparator: Group 4: RIV4; participants will receive a single dose of RIV4 vaccine	Biological: Quadrivalent Recombinant Influenza vaccine RIV4; Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular; Other Names: Flublok Quadrivalent®
Active Comparator: Group 5: QIV-SD; participants will receive a single dose of QIV-SD vaccine	Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD; Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular; Other Names: Fluzone Quadrivalent®
Active Comparator: Group 6: QIV-HD; participants will receive a single dose of QIV -HD vaccine	Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD; Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular; Other Names: Fluzone High-Dose Quadrivalent®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes after injection
Number of participants with solicited injection site reactions 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	Within 7 days after injection
Number of participants with unsolicited AEs	AEs that do not fulfill the conditions of solicited reactions	Within 28 days after injection
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	Within 180 days after injection
Number of participants with serious adverse events (SAEs)	SAEs reported throughout the study	From Day 1 until Day 366
Number of participants with out-of-range biological test results	Out-of-range biological test results (including shift from baseline values)	Within 8 days after injection
Individual Hemagglutination inhibition (HAI) titer	Antibody titers are expressed as GMTs at baseline and post-baseline	Day 1 and Day 29
Percentage of participants with detectable antibody HAI titers greater than or equal to (≥) 10 [1/dil]		Day 1 and Day 29
Individual HAI titer ratio	Ratios of antibody titers measured by HAI in each group before and after vaccination	Day 1 and Day 29
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	Day 1 and Day 29
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]		Day 29
Percentage of participants with 2-fold and 4-fold rise in HAI titers		Day 1 and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing Ab titers	Neutralizing Ab titers expressed as GMTs	Day 1 and Day 29
Individual neutralizing antibodies titer ratio		Day 1 and Day 29
Percentage of participants with 2-fold and 4-fold increase in neutralizing titers		Day 1 and Day 29
Individual HAI Ab titer ratio		Day 1, Day 91, Day 181 and Day 366
Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]		Day 91, Day 181 and Day 366
Individual antibodies HAI titer ratio		Day 1, Day 91, Day 181 and Day 366

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): March 28, 2024

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: VAV00020; U1111-1275-1516 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes