Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

Phase 1

Completed

Conditions: Influenza Immunization

Interventions: Biological: Quadrivalent Influenza mRNA Vaccine MRT5407
Biological: Quadrivalent Influenza Standard Dose Vaccine
Biological: Quadrivalent Influenza High-Dose Vaccine
Biological: Quadrivalent Recombinant Influenza Vaccine

Registration Number: NCT05553301

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 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.

Detailed Description: Study duration is approximately 12 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 560

Inclusion Criteria

Aged 18 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.

Exclusion Criteria

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
Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2	Quadrivalent Influenza mRNA Vaccine MRT5407	participants will receive a single dose of QIV mRNA vaccine (dose level 2)
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1	Quadrivalent Influenza mRNA Vaccine MRT5407	participants will receive a single dose of QIV mRNA vaccine (dose level 1)
Group 4: QIV-SD	Quadrivalent Influenza Standard Dose Vaccine	participants will receive a single dose of QIV-SD vaccine
Group 5: QIV-HD	Quadrivalent Influenza High-Dose Vaccine	participants will receive a single dose of QIV -HD vaccine (for elderly only)
Group 3: RIV4	Quadrivalent Recombinant Influenza Vaccine	participants will receive a single dose of RIV4 vaccine

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (25): Indago Research and Health Center Site Number : 8400014
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Hialeah, Florida, United States
Cenexel Research Centers of America Site Number : 8400048
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Hollywood, Florida, United States
Dade Research Center Site Number : 8400011
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Miami, Florida, United States
Suncoast Research Group, LLC Site Number : 8400038
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Miami, Florida, United States
Florida International Research Center Site Number : 8400051
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Miami, Florida, United States
Palm Beach Research Center Site Number : 8400020
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West Palm Beach, Florida, United States
DM Clinical Research Site Number : 8400032
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Melrose Park, Illinois, United States
DM Clinical Research - Chicago Site Number : 8400028
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River Forest, Illinois, United States
Brengle Family Medicine Site Number : 8400005
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Indianapolis, Indiana, United States
AMR Lexington Site Number : 8400054
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Lexington, Kentucky, United States
AMR Kansas City Site Number : 8400006
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Kansas City, Missouri, United States
Velocity Clinical Research Site Number : 8400003
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Omaha, Nebraska, United States
Elligo Health Research Site Number : 8400056
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Austin, Texas, United States
Clinical Trials of Texas, Inc. Site Number : 8400026
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San Antonio, Texas, United States
DM Clinical Research - Sugar Land Site Number : 8400031
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Sugar Land, Texas, United States
Investigational Site Number : 6300003
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Barrio Sabana, Puerto Rico
Peninsula Research Associates Site Number : 8400025
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Rolling Hills Estates, California, United States
Optimal Research Site Number : 8400059
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San Diego, California, United States
California Research Foundation Site Number : 8400008
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San Diego, California, United States
Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400052
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DeLand, Florida, United States
SIMEDHealth, LLC Site Number : 8400024
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Gainesville, Florida, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400010
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North Charleston, South Carolina, United States
AMR Knoxville Site Number : 8400046
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Knoxville, Tennessee, United States
Sun Research Institute Site Number : 8400030
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San Antonio, Texas, United States
Investigational Site Number : 6300002
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San Juan, Puerto Rico