{"id":"flumist-quadrivalent-2017-2018","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Runny nose","drugRate":"30%","severity":"Mild"},{"effect":"Sore throat","drugRate":"20%","severity":"Mild"},{"effect":"Fever","drugRate":"10%","severity":"Mild"},{"effect":"Headache","drugRate":"15%","severity":"Mild"},{"effect":"Muscle aches","drugRate":"10%","severity":"Mild"},{"effect":"Nasal congestion","drugRate":"25%","severity":"Mild"}],"contraindications":["Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine","Children and adolescents receiving aspirin or aspirin-containing therapy","Individuals with a history of Guillain-Barré syndrome within 6 weeks of a previous dose of influenza vaccine"],"specialPopulations":{"Pregnant women":"Not recommended","Adults 50 years and older":"Not approved","Children under 2 years of age":"Not approved","Immunocompromised individuals":"Not recommended"}},"trials":[],"_chembl":null,"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2017-02-22","type":"Approval","milestone":"FDA approval for the 2017-2018 season","regulator":"FDA"},{"date":"2017-09-01","type":"Launch","milestone":"Launch of FluMist Quadrivalent for the 2017-2018 season","regulator":"FDA"}],"_dailymed":null,"aiSummary":"FluMist Quadrivalent (2017-2018) is a live attenuated influenza vaccine (LAIV) developed by MedImmune LLC for the prevention of influenza. It is administered intranasally and contains four strains of the influenza virus. The vaccine is designed to stimulate an immune response in the nasal passages, where the virus typically enters the body. Despite its effectiveness, FluMist Quadrivalent has faced challenges, including concerns over efficacy in certain age groups and a lack of an FDA label. It is generally well-tolerated but can cause common side effects such as runny nose, sore throat, and fever. The vaccine is not recommended for individuals with certain medical conditions or for those who are pregnant.","ecosystem":[],"mechanism":{"target":"Influenza virus","novelty":"FluMist Quadrivalent was the first intranasal influenza vaccine approved in the United States, offering a needle-free alternative to traditional flu shots.","modality":"Vaccine","drugClass":"Live attenuated influenza vaccine (LAIV)","explanation":"The vaccine contains weakened forms of the influenza virus that can replicate in the cooler temperatures of the nasal passages but not in the warmer lungs, thus stimulating an immune response without causing disease.","oneSentence":"FluMist Quadrivalent is a live attenuated influenza vaccine that stimulates an immune response in the nasal passages to prevent influenza infection.","technicalDetail":"The vaccine consists of four strains of live attenuated influenza viruses (two A strains and two B strains) that are cold-adapted and temperature-sensitive, meaning they can replicate in the nasal passages but not in the lungs."},"_scrapedAt":"2026-03-28T00:39:43.996Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"2017-2018","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"Individuals 2 years to 49 years of age","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Fluzone (Sanofi Pasteur)","Fluarix (GlaxoSmithKline)","Flucelvax (Seqirus)"],"indications":{"approved":["Prevention of influenza in individuals 2 years to 49 years of age"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT02783170","phase":"PHASE4","title":"Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women","status":"COMPLETED","sponsor":"Duke University","startDate":"2016-09","conditions":"Pregnancy","enrollment":81},{"nctId":"NCT04896086","phase":"PHASE1","title":"First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2021-05-24","conditions":"Influenza, Seasonal Influenza","enrollment":63},{"nctId":"NCT06286488","phase":"PHASE4","title":"Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza","status":"ACTIVE_NOT_RECRUITING","sponsor":"Medical University of Warsaw","startDate":"2020-09-15","conditions":"Influenza, Obesity, Pregnancy; Infection","enrollment":1500},{"nctId":"NCT03391193","phase":"PHASE3","title":"Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2017-12-19","conditions":"Influenza","enrollment":301},{"nctId":"NCT03308825","phase":"PHASE4","title":"Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2017-09-11","conditions":"Influenza, Flu","enrollment":240},{"nctId":"NCT03314662","phase":"PHASE3","title":"Phase 3 Safety and Immunogenicity Study of aQIV in Elderly Adults","status":"COMPLETED","sponsor":"Seqirus","startDate":"2017-10-17","conditions":"Influenza, Human","enrollment":1778},{"nctId":"NCT03158038","phase":"PHASE4","title":"Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults for the 2017-2018 Season","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2017-05-30","conditions":"Influenza, Healthy","enrollment":300},{"nctId":"NCT03143101","phase":"PHASE4","title":"Evaluate the Shedding and Immunogencity of Different Formulations of FluMist in Children 24 to <48 Months of Age","status":"COMPLETED","sponsor":"MedImmune LLC","startDate":"2017-05-08","conditions":"Influenza, Healthy","enrollment":200}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"FluMist Quadrivalent (2017-2018)","genericName":"FluMist Quadrivalent (2017-2018)","companyName":"MedImmune LLC","companyId":"medimmune-llc","modality":"Biologic","firstApprovalDate":"2017-2018","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}