nctId: NCT06361875 id: VAV00045 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 overallStatus: RECRUITING date: 2024-04-01 date: 2025-05-22 date: 2025-05-22 date: 2024-04-12 date: 2024-04-12 name: Sanofi Pasteur, a Sanofi Company class: INDUSTRY 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. conditions: Influenza Immunization studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel with dose escalation for sentinel cohort primaryPurpose: PREVENTION 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 count: 1002 type: ESTIMATED name: Quadrivalent Influenza mRNA Vaccine MRT5421 name: Quadrivalent Influenza mRNA Vaccine MRT5424 name: Quadrivalent Influenza mRNA Vaccine MRT5429 name: Quadrivalent Influenza Standard Dose Vaccine name: Quadrivalent Influenza High-Dose Vaccine name: Quadrivalent Recombinant Influenza Vaccine measure: Number of participants with immediate unsolicited systemic adverse events (AEs) measure: Number of participants with solicited injection site reactions measure: Number of participants with solicited systemic reactions measure: Number of participants with unsolicited AEs measure: Number of participants with medically attended adverse events (MAAEs) measure: Number of participants with serious adverse events (SAEs) measure: AESIs reported throughout the study measure: Number of participants with adverse events of special interests (AESIs) measure: Number of participants with out-of-range biological test results measure: Geometric Mean Titer (GMT) measure: Geometric Mean of individual Titer Ratio (GMTR) measure: Seroconversion measure: HAI Ab titer ≥ 40 (1/dil) measure: Neutralizing Ab titers at D01 and D29 measure: Individual neutralizing antibodies titer ratio measure: 2-fold and 4-fold increase in neutralizing titers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research Site Number : 8400048 status: RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: California Research Foundation Site Number : 8400038 status: RECRUITING city: San Diego state: California zip: 92123-1881 country: United States lat: 32.71533 lon: -117.15726 facility: Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001 status: RECRUITING city: DeLand state: Florida zip: 32720-0834 country: United States lat: 29.02832 lon: -81.30312 facility: Indago Research and Health Center Site Number : 8400032 status: RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Centers of America Site Number : 8400037 status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Suncoast Research Group, LLC Site Number : 8400015 status: RECRUITING city: Miami state: Florida zip: 33135 country: United States lat: 25.77427 lon: -80.19366 facility: Brengle Family Medicine Site Number : 8400045 status: RECRUITING city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: AMR Lexington Site Number : 8400042 status: RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States lat: 37.98869 lon: -84.47772 facility: Velocity Clinical Research Site Number : 8400053 status: RECRUITING city: Metairie state: Louisiana zip: 70006 country: United States lat: 29.98409 lon: -90.15285 facility: Optimal Research, LLC Rockville Site Number : 8400025 status: RECRUITING city: Rockville state: Maryland zip: 20850 country: United States lat: 39.084 lon: -77.15276 facility: The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034 status: RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States lat: 39.09973 lon: -94.57857 facility: Velocity Clinical Research Norfolk Site Number : 8400046 status: RECRUITING city: Norfolk state: Nebraska zip: 68701 country: United States lat: 42.02834 lon: -97.417 facility: Velocity Clinical Research, Omaha Site Number : 8400008 status: RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Rochester Clinical Research. Inc. Site Number : 8400005 status: RECRUITING city: Rochester state: New York zip: 14609 country: United States lat: 43.15478 lon: -77.61556 facility: Aventiv Research Columbus Site Number : 8400020 status: RECRUITING city: Columbus state: Ohio zip: 43213 country: United States lat: 39.96118 lon: -82.99879 facility: Coastal Carolina Research Center Site Number : 8400014 status: RECRUITING city: North Charleston state: South Carolina zip: 29405 country: United States lat: 32.85462 lon: -79.97481 facility: AMR Knoxville Site Number : 8400043 status: RECRUITING city: Knoxville state: Tennessee zip: 37909 country: United States lat: 35.96064 lon: -83.92074 facility: Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029 status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 facility: DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056 status: RECRUITING city: Tomball state: Texas zip: 77375 country: United States lat: 30.09716 lon: -95.61605 facility: JBR Clinical Research Site Number : 8400051 status: RECRUITING city: Salt Lake City state: Utah zip: 84107 country: United States lat: 40.76078 lon: -111.89105 facility: Investigational Site Number : 6300002 status: RECRUITING city: Barrio Sabana zip: 00694 country: Puerto Rico hasResults: False