{"id":"quadrivalent-influenza-vaccine","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"GASTROINTESTINAL DISORDER","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"LIP SWELLING","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"SYNCOPE","source":"FDA FAERS","actionTaken":"Reported 4 times"},{"date":"","signal":"EPILEPSY","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"ABDOMINAL DISCOMFORT","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"ALOPECIA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"BLOOD TRIGLYCERIDES INCREASED","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"DEPRESSED MOOD","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"FOOD CRAVING","source":"FDA FAERS","actionTaken":"Reported 2 times"}],"drugInteractions":[{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Interferon-alpha","action":"Monitor","effect":"May enhance the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza 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diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live attenuated vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live virus vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"},{"drug":"Live vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza 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vaccines","action":"Avoid","effect":"May diminish the therapeutic effect of Quadrivalent Influenza Vaccine"}],"commonSideEffects":[],"contraindications":["A severe allergic reaction (eg, anaphylaxis) after previous dose of IIV3 or to a vaccine component","Moderate or severe acute illness with or without fever (vaccination is postponed until illness resolves)","Guillain-Barré syndrome(GBS) within 6 weeks after a previous dose of an influenza vaccine","A history of severe allergic reaction to a previous dose of any other influenza vaccine (ie, any egg-based IIV, RIV, or LAIV)","A severe allergic reaction (eg, anaphylaxis) to any vaccine component or to a previous dose of any influenza vaccine","Immunocompromise (eg, due to disorders, including HIV infection, or use of immunosuppressants)","For children and adolescents, concomitant use of aspirin or other salicylates","Close contact with and/or caring for severely immunocompromised patients who require a protected environment (unless contact is avoided for 7 days after receiving LAIV)","Pregnancy","Anatomical or functional asplenia","Receipt of influenza antiviral medications in the past 48 hours","Cerebrospinal fluid leak or a cochlear implant","Age < 2 years or ≥ 50 years","Age 2 to 4 years if children have asthma or have had wheezing or asthma episodes in the past 12 months","Asthma in people aged ≥ 5 years","Use of specific antiviral medications, eg, amantadine, rimantadine, zanamivir, oseltamivir (these medications are stopped 48 hours before vaccination and are not resumed for 14 days after vaccination)","A severe allergic reaction (eg, anaphylaxis) after a previous dose of RIV4"],"specialPopulations":{"Pregnancy":"Pregnant persons are considered a priority group for seasonal influenza vaccination to prevent influenza-related medical conditions [1,2,3]. Pregnant persons are at increased risk for morbidity and mortality due to influenza during pregnancy—especially with severe illness—are at increased risk of adverse outcomes, including preterm birth and low birth weight [4,5].","Geriatric use":"text","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[]},"trials":[],"aliases":["Influvax Tetra Vaccine","GC3110A","VaxigripTetra™","VaxigripTetra®","QIV"],"company":"International Centre for Diarrhoeal Disease Research, Bangladesh","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T22:57:54.187023+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T22:58:03.884779+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2109042/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T22:57:47.708084+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:58:05.354927+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:57:46.294296+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T22:57:47.318320+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:58:05.354875+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:58:05.354873+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:58:05.354825+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T22:58:05.354851+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"The Quadrivalent Influenza Vaccine, developed by the International Centre for Diarrhoeal Disease Research, Bangladesh, currently lacks a strong market position due to the absence of clinical trial data and brand recognition. Its mechanism of stimulating the immune system to produce antibodies against influenza viruses is a standard approach, but it faces significant competition from established brands like Tamiflu, Fluzone High-Dose, and Afluria, which offer specific advantages such as targeted efficacy in older adults or alternative treatment methods. A key risk for the vaccine is the lack of clinical trial data, which may hinder its adoption and regulatory approval, especially in markets where PD-L1 companion diagnostics are required for certain indications. The pipeline outlook remains uncertain without ongoing or planned clinical trials to demonstrate efficacy and safety, which are crucial for gaining a competitive edge in the crowded influenza vaccine market.","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Influenza viruses","novelty":"Best-in-class","modality":"Inactivated vaccine","drugClass":"Inactivated vaccine","explanation":"The Quadrivalent Influenza Vaccine is a type of vaccine that is designed to protect against four different strains of the influenza virus. It contains antigens from two influenza A subtype viruses (A/H1N1 and A/H3N2) and two influenza B viruses. When administered to a person, the vaccine stimulates the body's immune system to produce antibodies against these viruses, providing protection against infection. This is achieved through the activation of immune cells, such as T-cells and B-cells, which recognize and respond to the antigens present in the vaccine.","oneSentence":"This vaccine works by stimulating the body's immune system to produce antibodies against influenza viruses.","technicalDetail":"The vaccine contains inactivated influenza viruses, which are grown in cell cultures and then inactivated with a chemical or radiation. The inactivated viruses are then mixed with an adjuvant, which helps to stimulate the immune response. The vaccine is administered via injection, typically into the muscle of the upper arm."},"_companyIR":{"url":"https://www.international.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL2109042","maxPhase":"3.0","chirality":1,"parenteral":false,"availability":null,"moleculeType":"Vaccine component","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"annualCostUS":"$13,980.00","genericStatus":"Generic — off-patent","peakSalesEstimate":"Not publicly reported"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=Quadrivalent%20Influenza%20Vaccine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Quadrivalent Influenza Vaccine","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":5,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":6,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T22:58:03.884876+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Tamiflu","company":"Roche","advantage":"Used for the treatment or prevention of the flu, Tamiflu is an antiviral medicine that competes with Quadrivalent Influenza Vaccine by providing an alternative method of flu prevention and treatment."},{"name":"Fluzone High-Dose","company":"Sanofi Pasteur","advantage":"Fluzone High-Dose is a high-dose influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a more effective option for older adults and those with weakened immune systems."},{"name":"Fluvirin","company":"Novartis","advantage":"Fluvirin is a trivalent influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a more traditional option for flu prevention."},{"name":"Afluria","company":"Seqirus","advantage":"Afluria is a quadrivalent influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a similar option for flu prevention."},{"name":"Amantadine","company":"GlaxoSmithKline","advantage":"Amantadine is an antiviral medication that competes with Quadrivalent Influenza Vaccine by providing an alternative method of flu prevention and treatment."},{"name":"Fluad","company":"Seqirus","advantage":"Fluad is a high-dose influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a more effective option for older adults and those with weakened immune systems."},{"name":"Flucelvax Quadrivalent","company":"Novartis","advantage":"Flucelvax Quadrivalent is a quadrivalent influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a similar option for flu prevention."},{"name":"Flublok","company":"Sanofi Pasteur","advantage":"Flublok is a quadrivalent influenza vaccine that competes with Quadrivalent Influenza Vaccine by providing a similar option for flu prevention."},{"name":"Xofluza","company":"Genentech","advantage":"Xofluza is an antiviral medication that competes with Quadrivalent Influenza Vaccine by providing an alternative method of flu prevention and treatment."}],"genericName":"quadrivalent influenza vaccine","indications":{"approved":[{"name":"Prevention of influenza disease caused by influenza A subtype viruses (A/H1N1, A/H3N2) and influenza B viruses in people 6 months of age and older"},{"name":"Prevention of influenza disease caused by influenza A subtype viruses (A/H1N1, A/H3N2) and influenza B viruses in people 6 months of age and older, when the circulating influenza A and B viruses are expected to be well matched to the vaccine viruses."}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Quadrivalent Influenza Vaccine","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL2109042","moleculeType":"Vaccine component","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL2109042","pubchemSID":"134223736"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":null,"targetChemblId":null,"mechanismComment":null,"mechanismOfAction":"Biological vaccine - induces immune response"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":406,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[{"pmid":"41962984","title":"Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial.","authors":"Põder A, Ong-Lim AL, Rivera Medina DM, Zaman K, Makedonska I","journal":"Lancet Child Adolesc Health","pubDate":"2026 May"},{"pmid":"41962206","title":"Cost-effectiveness of vaccination of older adults with an MF59®-adjuvanted quadrivalent influenza vaccine compared to standard-dose and high-dose vaccines in South Korea and Taiwan.","authors":"Hsieh SM, Choi MJ, Chen YC, Cheng SY, Liu DP","journal":"Vaccine","pubDate":"2026 Apr 9"},{"pmid":"41600986","title":"Effectiveness of the Cell-Based Quadrivalent Influenza Vaccine (SKYCellflu(®) QIV) in Children and Adolescents: A Multicenter Test-Negative Case-Control Study in Korea.","authors":"Yoon Y, Jeong HS, Oh K, Choe YJ, Kang HM","journal":"Vaccines (Basel)","pubDate":"2026 Jan 8"},{"pmid":"41150407","title":"Reactogenicity of an Inactivated, Split-Virion Quadrivalent Influenza Vaccine in Infants and Children Aged ≥6 Months to <9 Years.","authors":"Nolan T, Albano FR, Oberije J, Piedrahita M, Hohenboken M","journal":"Vaccines (Basel)","pubDate":"2025 Sep 30"},{"pmid":"40909288","title":"Correction: The immunogenicity and safety of an inactivated quadrivalent influenza vaccine and a 23-valent pneumococcal polysaccharide vaccine in individuals with chronic diseases.","authors":"Frontiers Production Office","journal":"Front Immunol","pubDate":"2025"},{"pmid":"40821798","title":"The immunogenicity and safety of an inactivated quadrivalent influenza vaccine and a 23-valent pneumococcal polysaccharide vaccine in individuals with chronic diseases.","authors":"Tang W, Lu X, Zhu Z, Yu D, Liu H","journal":"Front Immunol","pubDate":"2025"},{"pmid":"40611765","title":"Cost-benefit analysis of a quadrivalent influenza vaccine in India.","authors":"Vora A, Tiwaskar M, Pai HD, Jones A, Kim K","journal":"J Med Econ","pubDate":"2025 Dec"},{"pmid":"40540779","title":"Recombinant quadrivalent influenza vaccine (RIV) induces robust cell-mediated and HA-specific B cell humoral immune responses among healthcare personnel.","authors":"Mishina M, Cao W, Ende Z, Sharma SS, Ray SD","journal":"Vaccine","pubDate":"2025 Aug 13"},{"pmid":"40432112","title":"Safety and Influenza Infections in Children Aged 6-35 Months Receiving Cell Culture-Derived Inactivated Quadrivalent Influenza Vaccine During the 2023-2024 Influenza Season in South Korea.","authors":"Lee HE, Park SB, Kim HY, Baik SH, Jung K","journal":"Vaccines (Basel)","pubDate":"2025 May 8"},{"pmid":"40431637","title":"Evaluation of Humoral and Cell-Mediated Immunity Induced by Quadrivalent Influenza Vaccine in Pre-COVID-19 Japan.","authors":"Otani N, Okuno T, Yamada K, Tsuchida T, Ishikawa K","journal":"Viruses","pubDate":"2025 Apr 26"}],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Quadrivalent Influenza Vaccine","companyName":"International Centre for Diarrhoeal Disease Research, Bangladesh","companyId":"international-centre-for-diarrhoeal-disease-research-bangladesh","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"13980.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":6,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T22:58:03.884876+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":false,"score":2}}