protocolSection identificationModule nctId: NCT06361875, orgStudyIdInfo id: VAV00045, secondaryIdInfos id: U1111-1295-2852, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-22, completionDateStruct date: 2025-05-22, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sanofi Pasteur, a Sanofi Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different formulations of Quadrivalent Influenza Vaccine (QIV) messenger ribonucleic acid (mRNA) (MRT5421, MRT5424, and MRT5429) 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., conditionsModule conditions: Influenza Immunization, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel with dose escalation for sentinel cohort, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Modified double-blind (Participants; Sites except for those preparing/administering study intervention; Sponsor's except Sponsor unblinded internal safety review committee), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1002, type: ESTIMATED, armsInterventionsModule interventions name: Quadrivalent Influenza mRNA Vaccine MRT5421, interventions name: Quadrivalent Influenza mRNA Vaccine MRT5424, interventions name: Quadrivalent Influenza mRNA Vaccine MRT5429, interventions name: Quadrivalent Influenza Standard Dose Vaccine, interventions name: Quadrivalent Influenza High-Dose Vaccine, interventions name: Quadrivalent Recombinant Influenza Vaccine, outcomesModule primaryOutcomes measure: Number of participants with immediate unsolicited systemic adverse events (AEs), primaryOutcomes measure: Number of participants with solicited injection site reactions, primaryOutcomes measure: Number of participants with solicited systemic reactions, primaryOutcomes measure: Number of participants with unsolicited AEs, primaryOutcomes measure: Number of participants with medically attended adverse events (MAAEs), primaryOutcomes measure: Number of participants with serious adverse events (SAEs), primaryOutcomes measure: AESIs reported throughout the study, primaryOutcomes measure: Number of participants with adverse events of special interests (AESIs), primaryOutcomes measure: Number of participants with out-of-range biological test results, primaryOutcomes measure: Geometric Mean Titer (GMT), primaryOutcomes measure: Geometric Mean of individual Titer Ratio (GMTR), primaryOutcomes measure: Seroconversion, primaryOutcomes measure: HAI Ab titer ≥ 40 (1/dil), secondaryOutcomes measure: Neutralizing Ab titers at D01 and D29, secondaryOutcomes measure: Individual neutralizing antibodies titer ratio, secondaryOutcomes measure: 2-fold and 4-fold increase in neutralizing titers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity Clinical Research Site Number : 8400048, status: RECRUITING, city: La Mesa, state: California, zip: 91942, country: United States, geoPoint lat: 32.76783, lon: -117.02308, locations facility: California Research Foundation Site Number : 8400038, status: RECRUITING, city: San Diego, state: California, zip: 92123-1881, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001, status: RECRUITING, city: DeLand, state: Florida, zip: 32720-0834, country: United States, geoPoint lat: 29.02832, lon: -81.30312, locations facility: Indago Research and Health Center Site Number : 8400032, status: RECRUITING, city: Hialeah, state: Florida, zip: 33012, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Centers of America Site Number : 8400037, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Suncoast Research Group, LLC Site Number : 8400015, status: RECRUITING, city: Miami, state: Florida, zip: 33135, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Brengle Family Medicine Site Number : 8400045, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: AMR Lexington Site Number : 8400042, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40509, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Velocity Clinical Research Site Number : 8400053, status: RECRUITING, city: Metairie, state: Louisiana, zip: 70006, country: United States, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Optimal Research, LLC Rockville Site Number : 8400025, status: RECRUITING, city: Rockville, state: Maryland, zip: 20850, country: United States, geoPoint lat: 39.084, lon: -77.15276, locations facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64114, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Velocity Clinical Research Norfolk Site Number : 8400046, status: RECRUITING, city: Norfolk, state: Nebraska, zip: 68701, country: United States, geoPoint lat: 42.02834, lon: -97.417, locations facility: Velocity Clinical Research, Omaha Site Number : 8400008, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, geoPoint lat: 41.25626, lon: -95.94043, locations facility: Rochester Clinical Research. Inc. Site Number : 8400005, status: RECRUITING, city: Rochester, state: New York, zip: 14609, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: Aventiv Research Columbus Site Number : 8400020, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Coastal Carolina Research Center Site Number : 8400014, status: RECRUITING, city: North Charleston, state: South Carolina, zip: 29405, country: United States, geoPoint lat: 32.85462, lon: -79.97481, locations facility: AMR Knoxville Site Number : 8400043, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37909, country: United States, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056, status: RECRUITING, city: Tomball, state: Texas, zip: 77375, country: United States, geoPoint lat: 30.09716, lon: -95.61605, locations facility: JBR Clinical Research Site Number : 8400051, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84107, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Investigational Site Number : 6300002, status: RECRUITING, city: Barrio Sabana, zip: 00694, country: Puerto Rico, hasResults: False