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

NCT05624606 | Completed Phase 1 FDA Drug

• 2 other identifiers: VAV00020U1111-1275-1516
• Study Type: interventional
• Target: 682
• Locations: 2 countries
• Sites: 25

Brief Summary

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.

Conditions

Influenza Immunization

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• Neutralizing Ab titers

  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

Study Arms (6)

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose

EXPERIMENTAL

participants will receive a single dose (low) of QIV mRNA vaccine

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose

EXPERIMENTAL

participants will receive a single dose (medium) of QIV mRNA vaccine

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

EXPERIMENTAL

participants will receive a single dose (high) of QIV mRNA vaccine

Biological: Quadrivalent Influenza mRNA Vaccine MRT5410

Group 4: RIV4

ACTIVE COMPARATOR

participants will receive a single dose of RIV4 vaccine

Biological: Quadrivalent Recombinant Influenza vaccine RIV4

Group 5: QIV-SD

ACTIVE COMPARATOR

participants will receive a single dose of QIV-SD vaccine

Biological: Quadrivalent Inactivated Influenza Standard Dose QIV-SD

Group 6: QIV-HD

ACTIVE COMPARATOR

participants will receive a single dose of QIV -HD vaccine

Biological: Quadrivalent Inactivated Influenza High Dose QIV-HD

Interventions

Quadrivalent Influenza mRNA Vaccine MRT5410 BIOLOGICAL

Pharmaceutical form: Liquid frozen solution for injection in a vial Route of administration: Intramuscular

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose; Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose; Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose

Quadrivalent Recombinant Influenza vaccine RIV4 BIOLOGICAL

Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular

Also known as: Flublok Quadrivalent®

Group 4: RIV4

Quadrivalent Inactivated Influenza Standard Dose QIV-SD BIOLOGICAL

Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular

Also known as: Fluzone Quadrivalent®

Group 5: QIV-SD

Quadrivalent Inactivated Influenza High Dose QIV-HD BIOLOGICAL

Pharmaceutical form: Liquid suspension for injection in prefilled syringe Route of administration: Intramuscular

Also known as: Fluzone High-Dose Quadrivalent®

Group 6: QIV-HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (25)

Joint Clinical Trials Huntington Park Site Number : 8400032

Huntington Park, California, 90255, United States

Location

Long Beach Clinical Trials Site Number : 8400056

Long Beach, California, 90806, United States

Location

Velocity Clinical Research, North Hollywood Site Number : 8400063

North Hollywood, California, 91606, United States

Location

California Research Foundation Site Number : 8400001

San Diego, California, 92123-1881, United States

Location

SIMEDHealth, LLC Site Number : 8400042

Gainesville, Florida, 32607, United States

Location

Indago Research and Health Center Site Number : 8400002

Hialeah, Florida, 33012, United States

Location

Research Centers of America Site Number : 8400011

Hollywood, Florida, 33024, United States

Location

Florida International Research Center Site Number : 8400009

Miami, Florida, 33173, United States

Location

Palm Beach Research Center Site Number : 8400041

West Palm Beach, Florida, 33409, United States

Location

Velocity Clinical Research Site Number : 8400024

Meridian, Idaho, 83642, United States

Location

Brengle Family Medicine Site Number : 8400040

Indianapolis, Indiana, 46260, United States

Location

AMR Lexington Site Number : 8400035

Lexington, Kentucky, 40509, United States

Location

Meridian Clinical Research Site Number : 8400017

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research Site Number : 8400034

Omaha, Nebraska, 68134, United States

Location

WR-CRCN, LLC Site Number : 8400060

Las Vegas, Nevada, 89106, United States

Location

Coastal Carolina Research Center - N Charleston Site Number : 8400007

North Charleston, South Carolina, 29405, United States

Location

AMR Knoxville Site Number : 8400021

Knoxville, Tennessee, 37919, United States

Location

Elligo Health Research, Inc. Site Number : 8400037

Austin, Texas, 78704, United States

Location

Tekton Research, Inc Site Number : 8400051

Austin, Texas, 78745, United States

Location

DM Clinical Research Site Number : 8400046

Humble, Texas, 77338, United States

Location

Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043

San Antonio, Texas, 78229, United States

Location

DM Clinical Research - Sugar Land Site Number : 8400045

Sugar Land, Texas, 77478, United States

Location

Martin Diagnostic Clinic Site Number : 8400058

Tomball, Texas, 77375, United States

Location

Investigational Site Number : 6300002

Barrio Sabana, 00694, Puerto Rico

Location

Investigational Site Number : 6300001

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a parallel-group prevention study with up to 6 arms that will be blinded to participants, investigators / sub-investigators, outcomes assessors, and laboratory personnel (with the exception of the sentinel safety portion of the study, which will be open-label). The Sponsor study staff will be unblinded (except laboratory testing personnel).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sentinel Cohort: Open label Main Cohort: * Open label (Sponsor, except laboratory testing personnel) * Blinded (Sites, except for those preparing/administering study intervention)

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: November 28, 2022
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (23); PR (2)