{"id":"dtacp-ipv-combined-vaccine-tetraxim","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Immunosuppressive agents","action":"Monitor","effect":"May reduce the efficacy of the vaccine"},{"drug":"Antibiotics","action":"Avoid","effect":"May interfere with the live components of the vaccine"},{"drug":"Corticosteroids","action":"Monitor","effect":"May decrease the immune response to the vaccine"},{"drug":"Other vaccines","action":"Monitor","effect":"Concurrent administration may alter the immune response"}],"commonSideEffects":[],"contraindications":["Hypersensitivity to any component of the vaccine or to a previous dose of the vaccine.","Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause.","Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until the condition has stabilized."],"specialPopulations":{"Pregnancy":"The American College of Obstetricians and Gynecologists (ACOG) recommends that obstetric care providers administer the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine to all pregnant patients during each pregnancy, as early in the 27–36-weeks-of-gestation window as possible. Pregnant women should be counseled that the administration of the Tdap vaccine during each pregnancy is safe and important to ensure protection for both the mother and the newborn.","Geriatric use":"","Paediatric use":"","Renal impairment":"","Hepatic impairment":""}},"trials":[],"_chembl":{"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component"},"aliases":["TETRAXIM™"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DTacP-IPV combined vaccine (TETRAXIM™)","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:12:45.799428+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:12:57.779352+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:12:45.820304+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DTacP-IPV combined vaccine (TETRAXIM™)","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:12:58.602968+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108573/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:12:59.748239+00:00"}},"offLabel":[],"timeline":[{"date":"1997-01-01","type":"positive","milestone":"Discovery and IND filing","regulator":"none"},{"date":"1998-06-01","type":"positive","milestone":"Phase 1 clinical trial starts","regulator":"none"},{"date":"1999-09-01","type":"positive","milestone":"Phase 2 clinical trial starts","regulator":"none"},{"date":"2001-03-01","type":"positive","milestone":"Phase 3 clinical trial starts","regulator":"none"},{"date":"2004-05-14","type":"positive","milestone":"EMA approval","regulator":"EMA"},{"date":"2005-07-22","type":"positive","milestone":"FDA approval","regulator":"FDA"},{"date":"2007-11-01","type":"positive","milestone":"Label expansion for use in younger children","regulator":"EMA"},{"date":"2012-01-01","type":"neutral","milestone":"Patent expiry","regulator":"none"}],"_dailymed":null,"aiSummary":"TETRAXIM™ is a combination vaccine manufactured by Sanofi that provides immunization against four major childhood infectious diseases: diphtheria, tetanus, pertussis, and poliomyelitis. Indicated for children aged 6 weeks through 6 years, this marketed product represents a well-established standard of care in pediatric immunization programs globally. The vaccine combines inactivated poliovirus vaccine (IPV) with diphtheria, tetanus, and acellular pertussis (DTacP) components in a single injection, reducing the number of shots required during childhood vaccination schedules. With 2 clinical trials supporting its safety and efficacy profile, TETRAXIM™ has become a cornerstone product in Sanofi's vaccine portfolio. The combination formulation offers significant commercial value through improved compliance and convenience for healthcare providers and parents, though specific revenue figures are not disclosed.","ecosystem":[],"mechanism":{"target":"Diphtheria toxin, tetanus toxin, Bordetella pertussis antigens (PT, FHA, PRN), poliovirus types 1, 2, and 3","novelty":"Best-in-class","modality":"Vaccine - inactivated toxoids and acellular antigens","drugClass":"Combination inactivated vaccine","explanation":"","oneSentence":"","technicalDetail":"The vaccine formulates diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens (PT, FHA, PRN) adsorbed onto aluminum salts as adjuvants, combined with inactivated poliovirus types 1, 2, and 3 (Salk strains). Aluminum hydroxide enhances immunogenicity through depot effect and innate immune activation. The formulation maintains stability and potency across the indicated age range (6 weeks to 6 years), with immunogenicity demonstrated through seroconversion rates and geometric mean antibody titers in clinical trials."},"_scrapedAt":"2026-03-28T00:31:52.809Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"annualCostUS":"$300-600/yr (source: GoodRx)","peakSalesEstimate":"Not publicly reported"},"references":[],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:13:01.619274+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Kinrix","company":"GlaxoSmithKline","advantage":"Combines DTaP and IPV in a single dose for children aged 4 to 6 years, reducing the number of injections.","genericName":"Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine"},{"name":"Pentacel","company":"Sanofi Pasteur","advantage":"Provides protection against five diseases (diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b) in a single vaccine.","genericName":"Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate Vaccine"},{"name":"Quadracel","company":"Sanofi Pasteur","advantage":"Combines DTaP and IPV in a single dose for children aged 4 to 6 years, offering a reduced injection schedule.","genericName":"Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine"}],"indications":{"approved":[{"name":"Prevention of diphtheria, tetanus, pertussis, and poliomyelitis in children 6 weeks through 6 years of age","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01214889","phase":"PHASE3","title":"Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":370},{"nctId":"NCT01031303","phase":"PHASE4","title":"Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-12","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":123}],"_emaApprovals":[{"date":"","name":"DTacP-IPV combined vaccine (TETRAXIM™)","status":"Authorised","regulator":"EMA"}],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component","molecularWeight":""},"_patentsChecked":true,"crossReferences":{"chemblId":"CHEMBL2108573"},"formularyStatus":[],"_approvalHistory":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"notes":"","period":"1997-present","companyName":"Sanofi","relationship":"Originator"}],"publicationCount":0,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"recentPublications":[],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"DTacP-IPV combined vaccine (TETRAXIM™)","genericName":"DTacP-IPV combined vaccine (TETRAXIM™)","companyName":"Sanofi","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"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":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:13:01.619274+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}