{"id":"qiv-hd","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain"},{"rate":null,"effect":"Injection site erythema"},{"rate":null,"effect":"Injection site swelling"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL378601","moleculeType":"Small molecule","molecularWeight":"371.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"QIV-HD contains four times the standard antigen dose (60 µg per strain vs. 15 µg in standard-dose QIV) to elicit a stronger humoral and cellular immune response. This higher antigen content is designed to improve immunogenicity and protective efficacy, particularly in older adults and immunocompromised populations who may have diminished responses to standard-dose vaccines.","oneSentence":"QIV-HD is a high-dose inactivated influenza vaccine that provides enhanced immune protection against four influenza virus strains.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:30:53.241Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of influenza A and B in adults, particularly older adults (≥65 years)"}]},"trialDetails":[{"nctId":"NCT07485855","phase":"PHASE3","title":"Influenza Vaccination Strategy for Patients With Hematologic Malignancy","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2025-12-04","conditions":"Hematologic Neoplasms, Influenza, Immunogenicity","enrollment":60},{"nctId":"NCT06431607","phase":"PHASE2","title":"A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2024-05-23","conditions":"Influenza, Human","enrollment":845},{"nctId":"NCT04613206","phase":"PHASE2","title":"High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2021-01-11","conditions":"Immunization; Infection, Transplantation Infection, Influenza","enrollment":396},{"nctId":"NCT04544267","phase":"PHASE3","title":"Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 35 Months of Age","status":"TERMINATED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2020-09-15","conditions":"Influenza","enrollment":100},{"nctId":"NCT05215327","phase":"PHASE2","title":"High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients","status":"RECRUITING","sponsor":"Vanderbilt University Medical Center","startDate":"2022-11-08","conditions":"Immunization; Infection, Transplantation Infection, Influenza","enrollment":270},{"nctId":"NCT04537234","phase":"PHASE3","title":"Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2020-11-10","conditions":"Influenza (Healthy Volunteers)","enrollment":165},{"nctId":"NCT04498832","phase":"PHASE3","title":"Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2020-10-21","conditions":"Influenza Immunization, Healthy Volunteers","enrollment":2100},{"nctId":"NCT04137887","phase":"PHASE3","title":"Study to Evaluate the Effectiveness of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Adults 65 Years of Age and Older","status":"TERMINATED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2019-11-04","conditions":"Influenza (Healthy Volunteers)","enrollment":33096},{"nctId":"NCT05426174","phase":"PHASE1","title":"Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2022-06-09","conditions":"Influenza Immunization, Healthy Volunteers","enrollment":233},{"nctId":"NCT05517174","phase":"PHASE4","title":"A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults","status":"COMPLETED","sponsor":"Tor Biering-Sørensen","startDate":"2022-09-22","conditions":"Influenza","enrollment":332438},{"nctId":"NCT04969276","phase":"PHASE2","title":"Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2021-07-16","conditions":"Influenza Immunization, Healthy Volunteers","enrollment":306},{"nctId":"NCT04024228","phase":"PHASE3","title":"Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Europeans Adults 60 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2019-10-28","conditions":"Influenza Immunization, Healthy Volunteers","enrollment":1539},{"nctId":"NCT06141655","phase":"PHASE4","title":"HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia","status":"COMPLETED","sponsor":"Federico Martinón Torres","startDate":"2023-10-26","conditions":"Influenza","enrollment":134476},{"nctId":"NCT06361875","phase":"PHASE1, PHASE2","title":"A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-04-01","conditions":"Influenza Immunization","enrollment":910},{"nctId":"NCT06744205","phase":"PHASE1, PHASE2","title":"A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2025-01-06","conditions":"Influenza, Healthy Volunteers","enrollment":1162},{"nctId":"NCT06134804","phase":"PHASE3","title":"A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2023-10-24","conditions":"Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention","enrollment":959},{"nctId":"NCT05947071","phase":"PHASE2","title":"High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2024-09-26","conditions":"Immunization; Infection, Transplantation Infection, Influenza","enrollment":312},{"nctId":"NCT05650554","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2022-12-12","conditions":"Influenza Immunization","enrollment":682},{"nctId":"NCT05624606","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2022-11-28","conditions":"Influenza Immunization","enrollment":682},{"nctId":"NCT05553301","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2022-10-03","conditions":"Influenza Immunization","enrollment":560},{"nctId":"NCT03179761","phase":"PHASE2","title":"High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients","status":"COMPLETED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2017-10-09","conditions":"Hematopoietic Cell Transplantation","enrollment":124},{"nctId":"NCT02860039","phase":"PHASE2","title":"High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant","status":"COMPLETED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2016-09","conditions":"Hematopoietic Cell Transplantation Recipient, Malignant Neoplasm, Influenza","enrollment":170},{"nctId":"NCT05559476","phase":"PHASE3","title":"A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-10-20","conditions":"Respiratory Syncytial Virus Infections","enrollment":1029},{"nctId":"NCT02936180","phase":"PHASE4","title":"Standard Versus High Dose Inactivated Influenza Vaccine in RA","status":"COMPLETED","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2016-10","conditions":"Rheumatoid Arthritis","enrollment":279},{"nctId":"NCT05007041","phase":"PHASE4","title":"Simultaneous RZV and aIIV4 Vaccination","status":"COMPLETED","sponsor":"Duke University","startDate":"2021-09-21","conditions":"Pain, Quality of Life, Injection Site Reaction","enrollment":267},{"nctId":"NCT04363359","phase":"PHASE2","title":"Clinical Trial of Quadrivalent Influenza Virus Split Vaccine","status":"COMPLETED","sponsor":"Shanghai Institute Of Biological Products","startDate":"2020-01-15","conditions":"Influenza","enrollment":1980},{"nctId":"NCT06029933","phase":"","title":"Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years","status":"RECRUITING","sponsor":"Kaiser Permanente","startDate":"2023-08-17","conditions":"Influenza, Community-acquired Pneumonia, Cardiovascular Events","enrollment":960000},{"nctId":"NCT04622592","phase":"PHASE1, PHASE2","title":"Adjuvanted Seasonal Recombinant Quadrivalent Virus-Like Particles (QVLP) Influenza Vaccine in Adults 65 Years of Age and Older","status":"COMPLETED","sponsor":"Medicago","startDate":"2020-11-02","conditions":"Influenza","enrollment":209},{"nctId":"NCT05048589","phase":"PHASE2","title":"Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting","status":"COMPLETED","sponsor":"Tor Biering-Sørensen","startDate":"2021-10-01","conditions":"Influenza","enrollment":12551},{"nctId":"NCT03282240","phase":"PHASE3","title":"Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2017-09-08","conditions":"Influenza","enrollment":2670},{"nctId":"NCT03698279","phase":"PHASE2","title":"Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-10-09","conditions":"Influenza","enrollment":665},{"nctId":"NCT03233217","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2017-09-15","conditions":"Influenza","enrollment":175},{"nctId":"NCT03068949","phase":"PHASE4","title":"Comparison of Three Licensed Influenza Vaccines","status":"COMPLETED","sponsor":"University of Rochester","startDate":"2015-10-28","conditions":"Influenza","enrollment":413},{"nctId":"NCT04143451","phase":"PHASE3","title":"Intradermal Influenza Vaccine With Topical Imiquimod in Elderly and Chronic Illness Patients","status":"UNKNOWN","sponsor":"The University of Hong Kong","startDate":"2019-10-23","conditions":"Influenza","enrollment":4000},{"nctId":"NCT02500680","phase":"PHASE1","title":"The Safety, Tolerance, and Immunogenicity of MAS-1-Adjuvanted Seasonal Inactivated Influenza Vaccine (MER4101)","status":"UNKNOWN","sponsor":"Nova Immunotherapeutics Limited","startDate":"2015-07","conditions":"Influenza, Human","enrollment":102}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":26,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["High-dose quadrivalent influenza vaccine"],"phase":"phase_3","status":"active","brandName":"QIV-HD","genericName":"QIV-HD","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi-pasteur-a-sanofi-company","modality":"Biologic","firstApprovalDate":"","aiSummary":"QIV-HD is a high-dose inactivated influenza vaccine that provides enhanced immune protection against four influenza virus strains. Used for Prevention of influenza A and B in adults, particularly older adults (≥65 years).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}