{"id":"tetanus-toxoid-reduced-diphtheria-toxoid-acellular-pertussis","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Pain at the injection site","drugRate":"64%","severity":"Mild to moderate"},{"effect":"Redness at the injection site","drugRate":"20%","severity":"Mild to moderate"},{"effect":"Swelling at the injection site","drugRate":"14%","severity":"Mild to moderate"},{"effect":"Headache","drugRate":"43%","severity":"Mild to moderate"},{"effect":"Fatigue","drugRate":"33%","severity":"Mild to moderate"},{"effect":"Muscle aches","drugRate":"29%","severity":"Mild to moderate"}],"contraindications":["History of encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine","Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to any component of the vaccine"],"specialPopulations":{"Elderly":"The vaccine is recommended for adults aged 65 years and older who have not previously received a Tdap vaccine.","Children":"The vaccine is not approved for use in children under 10 years of age.","Pregnant Women":"The vaccine is recommended during each pregnancy, ideally between 27 and 36 weeks gestation."}},"trials":[],"_chembl":{"chemblId":"CHEMBL2109121","moleculeType":"Vaccine component"},"aliases":["ADACEL®","NaCl"],"patents":[{"title":"Compositions and methods for inducing an immune response against Bordetella pertussis","number":"US7846441B2","issueDate":"2010-12-07","filingDate":"2005-03-18"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2005-06-10","type":"Approval","milestone":"First approval in the United States","regulator":"FDA"}],"_dailymed":{"setId":"cd98bff9-4602-4268-d68d-029a14a5513b","title":"BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]"},"aiSummary":"The Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis (Tdap) vaccine, manufactured by Sanofi Pasteur, is designed to protect against tetanus, diphtheria, and pertussis. It is a combination vaccine that contains inactivated toxins from the bacteria causing these diseases. The vaccine is recommended for adolescents and adults as a booster dose. Despite its effectiveness, it has not received an FDA label, which may affect its market presence. Common side effects include pain at the injection site, redness, and swelling, occurring in a significant percentage of recipients. The vaccine is generally well-tolerated but has specific contraindications and interactions that healthcare providers should consider.","ecosystem":[],"mechanism":{"target":"The vaccine targets the immune system to produce antibodies against tetanus, diphtheria, and pertussis toxins.","novelty":"The Tdap vaccine represents an advancement over older whole-cell pertussis vaccines, offering a reduced risk of adverse reactions while maintaining efficacy.","modality":"Prophylactic","drugClass":"Vaccine","explanation":"The vaccine contains inactivated toxins (toxoids) from Clostridium tetani, Corynebacterium diphtheriae, and acellular components of Bordetella pertussis. These components are not capable of causing disease but trigger an immune response that provides protection against future infections.","oneSentence":"The Tdap vaccine works by introducing inactivated toxins from the bacteria that cause tetanus, diphtheria, and pertussis, stimulating the immune system to produce antibodies against these pathogens.","technicalDetail":"The vaccine includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis antigens. The tetanus toxoid is a purified, inactivated form of the toxin produced by C. tetani, while the reduced diphtheria toxoid is a similar preparation from C. diphtheriae. The acellular pertussis component consists of purified proteins from B. pertussis, such as pertussis toxin, filamentous hemagglutinin, and pertactin."},"_scrapedAt":"2026-03-28T02:08:17.068Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available due to lack of FDA label","launchDate":"Not available due to lack of FDA label","annualCostUS":"Not available due to lack of FDA label","currentRevenue":"Not available due to lack of FDA label","patientPopulation":"Adolescents and adults aged 10 years and older","peakSalesEstimate":"Not available due to lack of FDA label"},"references":[],"biosimilars":[],"competitors":["GlaxoSmithKline (Boostrix)","Merck & Co. (Adacel)"],"indications":{"approved":["Prevention of tetanus, diphtheria, and pertussis in individuals aged 10 years and older"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07418372","phase":"PHASE1, PHASE2","title":"Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine","status":"NOT_YET_RECRUITING","sponsor":"Institute of Medical Biology, Chinese Academy of Medical Sciences","startDate":"2026-03-12","conditions":"Tetanus, Diphtheria and Acellular Pertussis Vaccination, Tetanus, Diphtheria","enrollment":660},{"nctId":"NCT05073003","phase":"PHASE1","title":"A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-10-06","conditions":"Diarrhoea","enrollment":551},{"nctId":"NCT05480800","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella and Typhoid Fever","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-09-13","conditions":"Salmonella Infections","enrollment":155},{"nctId":"NCT06798831","phase":"PHASE3","title":"Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"BioNet-Asia Co., Ltd.","startDate":"2025-02-08","conditions":"Pertussis Vaccine","enrollment":2399},{"nctId":"NCT06639074","phase":"PHASE2","title":"Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2024-11-08","conditions":"Advanced Fallopian Tube Carcinoma, Advanced Fallopian Tube High Grade Serous Adenocarcinoma, Advanced Ovarian Carcinoma","enrollment":78},{"nctId":"NCT04490018","phase":"PHASE3","title":"Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2021-03-16","conditions":"Meningococcal Immunisation, Healthy Volunteers","enrollment":463},{"nctId":"NCT04300192","phase":"PHASE4","title":"Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2021-01-27","conditions":"Pertussis Immunisation, Diphtheria Immunisation, Tetanus Immunisation","enrollment":273},{"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":"NCT05662852","phase":"PHASE2","title":"Safety and Immunogenicity Study of Tdap Vaccinations for Plasma Donors","status":"COMPLETED","sponsor":"ABO Holdings, Inc.","startDate":"2023-05-05","conditions":"Tetanus, Diphtheria and Acellular Pertussis Vaccination","enrollment":100},{"nctId":"NCT03589768","phase":"PHASE2","title":"Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-01-24","conditions":"Clostridium Difficile Immunisation, Diphtheria, Diphtheria Immunisation","enrollment":399},{"nctId":"NCT06056050","phase":"PHASE1","title":"A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)","status":"ACTIVE_NOT_RECRUITING","sponsor":"CanSino Biologics Inc.","startDate":"2023-12-06","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":180},{"nctId":"NCT06708286","phase":"PHASE2, PHASE3","title":"A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)","status":"ACTIVE_NOT_RECRUITING","sponsor":"CanSino Biologics Inc.","startDate":"2024-12-20","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1820},{"nctId":"NCT05613205","phase":"PHASE1","title":"Safety and Immunogenicity of a Novel Conjugate Vaccine Against Salmonella Typhi and Salmonella Paratyphi A in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-11-28","conditions":"Typhoid Fever","enrollment":97},{"nctId":"NCT05183516","phase":"PHASE1, PHASE2","title":"Tdap and Biomarkers of Alzheimer's Disease","status":"UNKNOWN","sponsor":"Mindful Diagnostics and Therapeutics, LLC","startDate":"2023-05-01","conditions":"Alzheimer Disease, Late Onset","enrollment":50},{"nctId":"NCT03958799","phase":"PHASE1","title":"A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2019-06-26","conditions":"Tetanus Immunisation (Healthy Volunteers), Diphtheria Immunisation (Healthy Volunteers), Pertussis Immunisation (Healthy Volunteers)","enrollment":71},{"nctId":"NCT02199691","phase":"PHASE2","title":"Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-07-22","conditions":"Meningitis, Meningococcal Meningitis, Meningococcal Infections","enrollment":1715},{"nctId":"NCT02992418","phase":"PHASE3","title":"Study of a Tetravalent Dengue Vaccine Administered Concomitantly or 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Vaccines","enrollment":682},{"nctId":"NCT00385255","phase":"PHASE3","title":"Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-10-23","conditions":"Acellular Pertussis, Diphtheria, Tetanus","enrollment":1726},{"nctId":"NCT00282295","phase":"PHASE4","title":"US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-01-25","conditions":"Acellular Pertussis, Tetanus, Diphtheria","enrollment":1344},{"nctId":"NCT00258882","phase":"","title":"Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-01","conditions":"Pertussis","enrollment":327293},{"nctId":"NCT02209623","phase":"","title":"TDAP Safety in Pregnant 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1)","status":"COMPLETED","sponsor":"Novartis","startDate":"2015-04","conditions":"Pertussis","enrollment":315},{"nctId":"NCT01933776","phase":"PHASE1","title":"Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2013-08","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":40},{"nctId":"NCT01629589","phase":"PHASE4","title":"Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2012-06","conditions":"Tetanus, Diphtheria, Pertussis","enrollment":423},{"nctId":"NCT01993173","phase":"PHASE3","title":"Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2013-11","conditions":"Diphtheria, 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Arthritis","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":2,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis","genericName":"Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis","companyName":"Sanofi Pasteur, a Sanofi Company","companyId":"sanofi","modality":"Biologic","firstApprovalDate":"Not available due to lack of FDA label","enrichmentLevel":3,"visitCount":1,"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":15,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}