{"id":"infanrix","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 39 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 16 times"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"Reported 15 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 13 times"},{"date":"","signal":"CRYING","source":"FDA FAERS","actionTaken":"Reported 11 times"},{"date":"","signal":"FOETAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"Reported 10 times"},{"date":"","signal":"DECREASED APPETITE","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"Reported 7 times"},{"date":"","signal":"MOVEMENT DISORDER","source":"FDA FAERS","actionTaken":"Reported 7 times"}],"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"Decreased immune response to vaccine"},{"drug":"Immune globulins","action":"Avoid","effect":"Decreased immune response to vaccine"},{"drug":"Blood products","action":"Avoid","effect":"Decreased immune response to vaccine"},{"drug":"Other vaccines","action":"Avoid","effect":"Decreased immune response to vaccine"},{"drug":"Interferon","action":"Avoid","effect":"Decreased immune response to vaccine"},{"drug":"Immunosuppressive drugs","action":"Avoid","effect":"Decreased immune response to vaccine"}],"commonSideEffects":[{"effect":"Irritability/Fussiness, any","drugRate":"62%","severity":"common","organSystem":""},{"effect":"Drowsiness, any","drugRate":"54%","severity":"common","organSystem":""},{"effect":"Pain, any (Dose 4)","drugRate":"48%","severity":"common","organSystem":""},{"effect":"Redness, any (Dose 4)","drugRate":"50%","severity":"common","organSystem":""},{"effect":"Swelling, any (Dose 4)","drugRate":"33%","severity":"common","organSystem":""},{"effect":"Loss of appetite, any","drugRate":"28%","severity":"common","organSystem":""},{"effect":"Fever (≥100.4°F)","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Redness, any (Dose 3)","drugRate":"39%","severity":"common","organSystem":""},{"effect":"Pain, any (Dose 4 booster)","drugRate":"46.5%","severity":"common","organSystem":""},{"effect":"Swelling, any (Dose 3)","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Increase in mid-thigh circumference, any","drugRate":"29.5%","severity":"common","organSystem":""},{"effect":"Drowsiness, Grade 2 or 3","drugRate":"18%","severity":"common","organSystem":""},{"effect":"Irritability/Fussiness, Grade 2 or 3","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Pain, Grade 2 or 3","drugRate":"19%","severity":"common","organSystem":""},{"effect":"Fever (>101.3°F)","drugRate":"8%","severity":"common","organSystem":""},{"effect":"Fever (>99.5°F) Dose 4","drugRate":"12%","severity":"common","organSystem":""},{"effect":"Redness, >20 mm","drugRate":"6%","severity":"common","organSystem":""},{"effect":"Swelling, >20 mm","drugRate":"4.5%","severity":"common","organSystem":""},{"effect":"Loss of appetite, Grade 2 or 3","drugRate":"4.3%","severity":"common","organSystem":""},{"effect":"Pain, Grade 3","drugRate":"3.5%","severity":"common","organSystem":""}],"contraindications":["INFANRIX-IPV should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, or inactivated poliomyelitis vaccines.","INFANRIX-IPV is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine.","As with other vaccines, the administration of INFANRIX-IPV should be postponed in subjects suffering from acute severe febrile illness.","Temperature of  40.0 °C (rectal) within 48 hours, not due to another identifiable cause","Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination","Persistent, inconsolable crying lasting  3 hours, occurring within 48 hours of vaccination","Convulsions with or without fever, occurring within 3 days of vaccination","In children with progressive neurological disorders, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis (Pa or Pw) vaccination","INFANRIX-IPV should be administered with caution to subjects with thrombocytopenia or a history of bleeding disorders"],"specialPopulations":{"Pregnancy":"Not mentioned","Geriatric use":"Not mentioned","Paediatric use":"Safety and effectiveness of INFANRIX in infants aged younger than 6 weeks and children aged 7 to 16 years have not been established.","Renal impairment":"Not mentioned","Hepatic impairment":"Not mentioned"},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_fixedAt":"2026-03-30T11:37:11.197241","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=infanrix","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:50:54.386139+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Infanrix","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:51:02.634838+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:51:01.164894+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:50:54.454144+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=infanrix","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:51:01.588478+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Pertactin autotransporter vaccine antigen","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:51:02.634771+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068350/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:51:02.294575+00:00"}},"offLabel":[],"timeline":[{"date":"20th century","type":"positive","_source":"Wikipedia","milestone":"Advancements in vaccinations reduce childhood pertussis incidence","regulator":"none"},{"date":"early 21st century","type":"neutral","_source":"Wikipedia","milestone":"Reported instances of pertussis increase 20-fold","regulator":"none"}],"_dailymed":{"setId":"de16dd6a-859b-4180-c6af-f930be14f26a","title":"INFANRIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS VACCINE ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]","labeler":""},"aiSummary":"Infanrix is a marketed vaccine by Pfizer Inc. It protects against diphtheria, tetanus, and pertussis in infants and children. The vaccine contains diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. This combination provides broad protection against these infectious diseases. Infanrix has a generic version with multiple manufacturers, indicating a well-established market presence. The vaccine's mechanism is based on inactivated toxins to generate an immune response. Its commercial significance lies in its widespread use for infant and childhood vaccinations.","brandName":"Infanrix","ecosystem":[],"isGeneric":true,"mechanism":{"novelty":"me-too","modality":"vaccine","drugClass":"vaccine","explanation":"","oneSentence":"","technicalDetail":"Infanrix contains diphtheria toxoid, tetanus toxoid, and either whole-cell pertussis or acellular pertussis antigens. The vaccine's mechanism involves the generation of an immune response against these pathogens, providing protection against diphtheria, tetanus, and pertussis. This is achieved through the use of inactivated toxins, which stimulate the body's immune system to produce antibodies against these pathogens."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"DPT vaccine","extract":"The DPT vaccine or DTP vaccine is a class of combination vaccines to protect against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). The vaccine components include diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either \"DTwP\" or \"DTaP\", where the lower-case \"w\" indicates whole-cell inactivated pertussis and the lower-case \"a\" stands for \"acellular\". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.","wiki_history":"== History ==\nthumb| An adherent, dense, grey [[pseudomembrane covering the tonsils is classically seen in diphtheria]]\nDiphtheria and tetanus toxoids and whole-cell Since the introduction of the combination vaccine, there has been an extensive decline in the incidence of pertussis, or whooping cough, the disease which the vaccine protects against. Additionally, the rates of disease have continued to decline as more extensive immunization strategies have been implemented, including booster doses and increased emphasis on increasing health literacy.\n\nIn the 20th century, the advancements in vaccinations helped to reduce the incidence of childhood pertussis and had a dramatically positive effect on the health of populations in the United States. However, in the early 21st century, reported instances of the disease increased 20-fold due to a downturn in the number of immunizations received and resulted in numerous fatalities. During the 21st century, many parents declined to vaccinate their children against pertussis for fear of perceived side effects, despite scientific evidence showing vaccines to be highly effective and safe.\n\n=== Vaccination rates ===\nIn 2016, the US Centers for Disease Control and Prevention (CDC) reported that 80.4% of children in the US had received four or more DTaP vaccinations by 2 years of life. Vaccination rates for children aged 13–17 with one or more TDaP shots was 90.2% in 2019.\n\nThe World Health Organization (WHO) estimated that 89% of people glo"},"commercial":{"annualCostUS":"Generic — multiple manufacturers","genericStatus":"Generic — off-patent","currentRevenue":"Generic — multiple manufacturers","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":"Generic — multiple manufacturers"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=infanrix","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=infanrix","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/infanrix","fields":["history","overview"],"source":"Wikipedia"},{"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":0,"lastValidatedAt":"2026-04-19T23:51:04.003618+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Boostrix (Tdap)","company":"GlaxoSmithKline","advantage":"May be used for pertussis prophylaxis, tetanus prophylaxis, and diphtheria prophylaxis"},{"name":"Adacel (Tdap)","company":"Sanofi Pasteur","advantage":"May be used for pertussis prophylaxis, tetanus prophylaxis, and diphtheria prophylaxis"},{"name":"Daptacel (DTaP)","company":"Sanofi Pasteur","advantage":"Used for tetanus prophylaxis"},{"name":"Decavac (Td)","company":"Sanofi Pasteur","advantage":"Used for diphtheria and tetanus toxoids / pertussis, acellular"},{"name":"Pentacel","company":"Sanofi Pasteur","advantage":"Used for pertussis prophylaxis"}],"genericName":"infanrix","indications":{"approved":[{"name":"Prevention of diphtheria, tetanus, and pertussis in infants and children aged 6 weeks through 6 years","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.infanrix.com","content":"1\nHIGHLIGHTS OF PRESCRIBING INFORMATION\nThese highlights do not include all the information needed to use\nINFANRIX safely and effectively. See full prescribing information for\nINFANRIX.\nINFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis\nVaccine Adsorbed) Suspension for Intramuscular Injection\nInitial U.S. Approval: 1997\n----------------------------- INDICATIONS AND USAGE----------------------------\nINFANRIX is a vaccine indicated for active immunization against diphtheria,\ntetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks\nthrough 6 years (prior to the seventh birthday). (1)\n------------------------- DOSAGE AND ADMINISTRATION -----------------------\nA 0.5-mL intramuscular injection given as a 5-dose series: (2.2)\n• One dose each at 2, 4, and 6 months of age.\n• One booster dose at 15 to 20 months of age and another booster dose at 4\nto 6 years of age.\n----------------------- DOSAGE FORMS AND STRENGTHS----------------------\nSingle-dose, prefilled syringes containing a 0.5-mL suspension for injection.\n(3)\n-------------------------------- CONTRAINDICATIONS ------------------------------\n• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any\ndiphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or to\nany component of INFANRIX. (4.1)\n• Encephalopathy within 7 days of administration of a previous\npertussis-containing vaccine. (4.2)\n• Progressive neurologic disorders. (4.3)\n------------------------- WARNINGS AND PRECAUTIONS------------------------\n• If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior\nvaccine containing tetanus toxoid, the decision to give INFANRIX should\nbe based on potential benefits and risks. (5.1)\n• Syncope (fainting) can occur in association with administration of\ninjectable vaccines, including INFANRIX. Procedures should be in place\nto avoid falling injury and to restore cerebral perfusion following\nsyncope. (5.2)\n• If temperature ≥105°F, collapse or shoc"},"_fixedFields":["pubmed(133)"],"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05237947","phase":"PHASE4","title":"Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-03-01","conditions":"Human Papillomavirus-Related Cervical Carcinoma","enrollment":5000},{"nctId":"NCT07097012","phase":"PHASE4","title":"Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy","status":"RECRUITING","sponsor":"Canadian Immunization Research Network","startDate":"2025-10-16","conditions":"RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination, Pregnancy","enrollment":60},{"nctId":"NCT07418372","phase":"PHASE1, PHASE2","title":"Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) 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