{"id":"pediarix","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"EXTRA DOSE ADMINISTERED","source":"FDA FAERS","actionTaken":"Reported 3 times"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"EXPIRED PRODUCT ADMINISTERED","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"INCORRECT DOSE ADMINISTERED","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 2 times"},{"date":"","signal":"ABNORMAL FAECES","source":"FDA FAERS","actionTaken":"Reported 1 times"},{"date":"","signal":"ACUTE RESPIRATORY FAILURE","source":"FDA FAERS","actionTaken":"Reported 1 times"}],"drugInteractions":[{"drug":"Ampicillin","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Ampicillin, Chloramphenicol, and other antibiotics","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Immune globulins","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Interferon","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Other inactivated vaccines","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Live vaccines","action":"Avoid","effect":"Decreased antibody response to Pediarix"},{"drug":"Thalidomide","action":"Avoid","effect":"Decreased antibody response to Pediarix"}],"commonSideEffects":[{"effect":"Local injection site reactions (pain, redness, and swelling)","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Fever (≥100.4°F)","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Drowsiness","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Irritability/fussiness","drugRate":"25%","severity":"common","organSystem":""},{"effect":"Loss of appetite","drugRate":"25%","severity":"common","organSystem":""}],"contraindications":["Severe allergic reactions (e.g., anaphylaxis) to any component of Pediarix, to previous doses of any vaccine containing diphtheria toxoid, tetanus toxoid, pertussis, hepatitis B, or Haemophilus influenzae type b (Hib) antigens, or to any component of the vaccine."],"seriousAdverseEvents":[]},"trials":[],"_chembl":null,"aliases":[],"company":"Pfizer Inc.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=pediarix","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:50:50.559182+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Pediarix","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:50:58.820935+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:50:57.411253+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:50:50.585384+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pediarix","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:50:58.265952+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"b63c4c7d-3dbf-419d-84cc-2c1957b92be7","title":"PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]","labeler":""},"aiSummary":"Pediarix is a combination vaccine developed by Pfizer Inc. It protects against diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B. The vaccine is administered in a 3-dose series to infants and children from 6 weeks through 6 years of age. Pediarix is a DTaP-IPV-HepB vaccine, which is a combination of diphtheria and tetanus toxoids, acellular pertussis, inactivated polio vaccine, and hepatitis B. This vaccine is a crucial component in the prevention of infectious diseases in children. Its commercial significance is evident in its revenue generation over 2 decades. The vaccine's clinical differentiation lies in its ability to protect against multiple diseases with a single dose.","brandName":"Pediarix","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Immune system","novelty":"me-too","modality":"vaccine","drugClass":"vaccine","explanation":"","oneSentence":"","technicalDetail":"The DTaP-IPV-HepB vaccine contains a combination of inactivated toxins, bacteria, and viruses that stimulate an immune response to prevent infection. The vaccine is administered in a series of doses to ensure optimal protection against the five diseases. The exact mechanism of action is not fully understood, but it is believed to involve the stimulation of immune cells, such as T-cells and B-cells, to produce antibodies and activate immune responses."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_scrapedAt":"2026-03-28T00:43:56.006Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"title":"DTaP-IPV-HepB vaccine","extract":"DTaP-IPV-HepB vaccine is a combination vaccine whose generic name is diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated polio vaccine or DTaP-IPV-Hep B. It protects against the infectious diseases diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B."},"commercial":{"annualCostUS":"$","genericStatus":"Generic — off-patent","currentRevenue":"2 decades","patientPopulation":"2 decades","peakSalesEstimate":"Not publicly reported"},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=pediarix","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=pediarix","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/pediarix","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":"2026-04-19T23:51:00.579280+00:00","fieldsConflicting":1,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Engerix-B","company":"GlaxoSmithKline","advantage":"Engerix-B is a recombinant hepatitis B vaccine that provides protection against hepatitis B virus infection.","genericName":"Hepatitis B vaccine, recombinant"},{"name":"Havrix","company":"GlaxoSmithKline","advantage":"Havrix is a combination vaccine that provides protection against both hepatitis A and hepatitis B virus infections.","genericName":"Hepatitis A vaccine, inactivated"},{"name":"Pentacel","company":"Sanofi Pasteur","advantage":"Pentacel is a combination vaccine that provides protection against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b infections.","genericName":"Diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, and Haemophilus influenzae type b conjugate vaccine"},{"name":"Kinrix","company":"GlaxoSmithKline","advantage":"Kinrix is a combination vaccine that provides protection against diphtheria, tetanus, pertussis, and polio infections.","genericName":"Diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus vaccine"},{"name":"Adacel","company":"Sanofi Pasteur","advantage":"Adacel is a combination vaccine that provides protection against tetanus, diphtheria, and pertussis infections.","genericName":"Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine"}],"genericName":"pediarix","indications":{"approved":[{"name":"Protection against diphtheria, tetanus, pertussis (whole-cell), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b (Hib) disease in infants and children from 6 weeks through 6 years of age."},{"name":"Protection against diphtheria, tetanus, pertussis (whole-cell), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b (Hib) disease in infants and children from 6 weeks through 6 years of age, when used in a 3-dose series."}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.pediarix.com","content":"For US Healthcare Professionals\n\nPrescribing Information\nGSKMedInfo\nOrder PEDIARIX\n\nSEARCH\n\nSUPPLY RELIABILITY\nSCHEDULE FLEXIBILITY\nEFFICACY & SAFETY\nCUSTOMER SOLUTIONS\nVIDEO CENTER\nLEARN ABOUT HIBERIX\nGSK: COMMITMENT YOU CAN COUNT ON\nService. Value. Relationship.\n\nJoin us in celebrating more than 2 decades of uninterrupted supply1,2 \n\nORDER PEDIARIX \n\n \n\nIndication for PEDIARIX\n\nPEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).\n\n \n\nWhy choose PEDIARIX?\n\nSCHEDULE FLEXIBILITY \n\nPEDIARIX has the broadest age indication among combination DTaP vaccines—as early as 6 weeks of age up until the 7th birthday.1,3,4\n\nSAVINGS \n\nPrograms and memberships designed to give you maximum portfolio discounts, GSK’s best private pricing, and other contract benefits.\n\nSUPPLY RELIABILITY \n\nLearn about the history of DTaP vaccine supply and the role PEDIARIX played.\n\nPERTUSSIS IS ACTIVE IN THE UNITED STATES5,6\n\nSee the data on this serious, highly contagious disease.5,6\n\n \n\nDID YOU KNOW? \n\nPEDIARIX is available in color-coded, single-dose, prefilled syringes to help with easy and quick identification.1\n\n \n\nDTaP=diphtheria, tetanus, and acellular pertussis.\n\nINDICATIONS FOR PEDIARIX, INFANRIX, AND KINRIX\n\nPEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).  \n\nINFANRIX is indicated for active immunization against diphtheria, "},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03621670","phase":"PHASE3","title":"Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-07-27","conditions":"Infections, Meningococcal","enrollment":1196},{"nctId":"NCT07160244","phase":"PHASE3","title":"BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","status":"RECRUITING","sponsor":"Pfizer","startDate":"2025-08-25","conditions":"Healthy","enrollment":6000},{"nctId":"NCT00505063","phase":"PHASE2","title":"Prospective Trial of Vaccine Responses in Childhood Cancer Survivors","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2007-07-10","conditions":"Childhood Cancer, Multiple Diseases","enrollment":76},{"nctId":"NCT01129362","phase":"","title":"Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2010-02-08","conditions":"Pertussis","enrollment":1195},{"nctId":"NCT03207750","phase":"PHASE3","title":"This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-09-14","conditions":"Rotavirus Infection, Rotavirus Vaccines","enrollment":1280},{"nctId":"NCT02096263","phase":"PHASE3","title":"Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-04-16","conditions":"Poliomyelitis, Diphtheria, Haemophilus Influenzae Type b","enrollment":585},{"nctId":"NCT00614614","phase":"PHASE3","title":"Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-13","conditions":"Infections, Meningococcal","enrollment":1558},{"nctId":"NCT01978093","phase":"PHASE3","title":"Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. 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