Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

NCT05650554 | Completed Phase 1 FDA Drug

• 2 other identifiers: VAV00029U1111-1279-3180
• Study Type: interventional
• Target: 682
• Locations: 3 countries
• Sites: 35

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 messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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.

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 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

  Up to 7 days after injection

• Number of participants with unsolicited AEs

  AEs that do not fulfill the conditions of solicited reactions

  Up to 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

  Up to 180 days after injection

• Number of participants with serious adverse events (SAEs)

  SAEs reported throughout the study

  From Day one to Day 366

• Number of participants with out-of-range biological test results

  Out-of-range biological test results (including shift from baseline values)

  Up to 8 days after injection

• Individual Hemagglutination inhibition (HAI) titer

  Antibody titers are expressed as GMTs at baseline and post-baseline

  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

• Individual HAI titer ratio

  Ratios of antibody titers measured by HAI in each group before and after vaccination

  At 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

  At Day 1 and Day 29

• Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

  At Day 29

• Percentage of participants with 2-fold and 4-fold rise in HAI titers

  At Day 1 and Day 29

Secondary Outcomes (6)

• Neutralizing Ab titers

  At Day 1 and Day 29

• 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

• Percentage of participants with antibody HAI titers greater than or equal to (≥) 40 [1/dil]

  At Day 91, Day 181 and Day 366

Study Arms (6)

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose

EXPERIMENTAL

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

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose

EXPERIMENTAL

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

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose

EXPERIMENTAL

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

Biological: Quadrivalent Influenza mRNA Vaccine MRT5413

Group 4: RIV4

ACTIVE COMPARATOR

participants will receive a single dose of RIV4 vaccine

Biological: Quadrivalent Recombinant Influenza Vaccine

Group 5: QIV-SD

ACTIVE COMPARATOR

participants will receive a single dose of QIV-SD vaccine

Biological: Quadrivalent Influenza Standard Dose Vaccine

Group 6: QIV-HD

ACTIVE COMPARATOR

participants will receive a single dose of QIV -HD vaccine (for elderly only)

Biological: Quadrivalent Influenza High-Dose Vaccine

Interventions

Quadrivalent Influenza mRNA Vaccine MRT5413 BIOLOGICAL

Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Group 1: Quadrivalent Influenza mRNA Vaccine MRT5413 low dose; Group 2: Quadrivalent Influenza mRNA Vaccine MRT5413 medium dose; Group 3: Quadrivalent Influenza mRNA Vaccine MRT5413 high dose

Quadrivalent Recombinant Influenza Vaccine BIOLOGICAL

Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection

Also known as: Flublok Quadrivalent®

Group 4: RIV4

Quadrivalent Influenza Standard Dose Vaccine BIOLOGICAL

Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection

Also known as: Fluzone Qudrivalent®

Group 5: QIV-SD

Quadrivalent Influenza High-Dose Vaccine BIOLOGICAL

Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe Route of Administration: Intramuscular injection

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:

• 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
• 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 (35)

Velocity Clinical Research-Chula Vista Site Number : 8400061

Chula Vista, California, 91911, United States

Location

Velocity Gardena Site Number : 8400062

Gardena, California, 90247, United States

Location

Long Beach Clinical Trials Site Number : 8400052

Long Beach, California, 90806, United States

Location

Velocity Clinical Research, North Hollywood Site Number : 8400051

North Hollywood, California, 91606, United States

Location

California Research Foundation Site Number : 8400006

San Diego, California, 92123-1881, United States

Location

Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032

DeLand, Florida, 32720-0834, United States

Location

Velocity New Smyrna Beach Site Number : 8400063

Edgewater, Florida, 32132, United States

Location

SIMEDHealth, LLC Site Number : 8400014

Gainesville, Florida, 32607, United States

Location

Indago Research and Health Center Site Number : 8400044

Hialeah, Florida, 33012, United States

Location

Cenexel Research Centers of America Site Number : 8400011

Hollywood, Florida, 33024, United States

Location

Florida International Research Center Site Number : 8400045

Miami, Florida, 33173, United States

Location

Suncoast Research Associates, LLC Site Number : 8400060

Miami, Florida, 33173, United States

Location

Florida Pulmonary Research Center Site Number : 8400036

Winter Park, Florida, 32789, United States

Location

Meridian Clinical Research Site Number : 8400022

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research Site Number : 8400024

Meridian, Idaho, 83642, United States

Location

DM Clinical Research - Chicago Site Number : 8400025

River Forest, Illinois, 60305, United States

Location

Brengle Family Medicine Site Number : 8400039

Indianapolis, Indiana, 46260, United States

Location

Velocity Clinical Research Lincoln Site Number : 8400049

Lincoln, Nebraska, 68510, United States

Location

Meridian Clinical Research Site Number : 8400017

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research Site Number : 8400008

Omaha, Nebraska, 68134, United States

Location

Rochester Clinical Research. Inc. Site Number : 8400027

Rochester, New York, 14609, United States

Location

Velocity Clinical Research Site Number : 8400001

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research - Providence Site Number : 8400019

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Carolina Research Center Site Number : 8400042

North Charleston, South Carolina, 29405, United States

Location

ClinSearch Site Number : 8400013

Chattanooga, Tennessee, 37421, United States

Location

Elligo Health Research, Inc. Site Number : 8400002

Austin, Texas, 78704, United States

Location

DM Clinical Research- Bellaire Site Number : 8400026

Houston, Texas, 77081, United States

Location

Clinical Trials of Texas, Inc. - PPDS Site Number : 8400016

San Antonio, Texas, 78229, United States

Location

Investigational Site Number : 0360004

Darlinghurst, New South Wales, 2010, Australia

Location

Investigational Site Number : 0360005

Kanwal, New South Wales, 2259, Australia

Location

Investigational Site Number : 0360003

Maroubra, New South Wales, 2035, Australia

Location

Investigational Site Number : 0360001

Morayfield, Queensland, 4506, Australia

Location

Investigational Site Number : 0360002

North Melbourne, Victoria, 3051, Australia

Location

Investigational Site Number : 6300001

Barrio Sabana, 00694, Puerto Rico

Location

Investigational Site Number : 6300002

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Viral Vaccines

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: December 6, 2022
• First Posted: December 14, 2022
• Study Start: December 12, 2022
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (28); AU (5); PR (2)