{"id":"pediarix-infanrix-penta","safety":{"commonSideEffects":[{"rate":"25-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-25","effect":"Fever"},{"rate":"10-20","effect":"Irritability"},{"rate":"5-15","effect":"Drowsiness"},{"rate":"5-10","effect":"Loss of appetite"}]},"_chembl":{"chemblId":"CHEMBL2385496","moleculeType":"Unknown","molecularWeight":"1060.12"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated toxoids of diphtheria and tetanus, acellular pertussis antigens, hepatitis B surface antigen, and inactivated poliovirus types 1, 2, and 3. These components trigger adaptive immune responses, generating humoral and cellular immunity to protect against these five infectious diseases. The vaccine is administered intramuscularly in infants and young children as part of routine immunization schedules.","oneSentence":"Pediarix/Infanrix Penta is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:25:59.822Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children"}]},"trialDetails":[{"nctId":"NCT00289783","phase":"PHASE3","title":"Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-02-22","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":4441},{"nctId":"NCT00611559","phase":"PHASE4","title":"Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-14","conditions":"Poliomyelitis, Acellular Pertussis, Tetanus","enrollment":283},{"nctId":"NCT00345579","phase":"PHASE3","title":"Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":4432},{"nctId":"NCT00345683","phase":"PHASE3","title":"Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-07","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":4021},{"nctId":"NCT00322335","phase":"PHASE3","title":"Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-05","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":230},{"nctId":"NCT00879827","phase":"PHASE3","title":"Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2000-09","conditions":"Diphtheria, Poliomyelitis, Hepatitis B","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Pediarix/Infanrix Penta","genericName":"Pediarix/Infanrix Penta","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"Pediarix/Infanrix Penta is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis. Used for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}