{"id":"dtpa-hbv-ipv-infanrix-penta","safety":{"commonSideEffects":[{"rate":"10-50","effect":"Injection site reactions (pain, redness, swelling)"},{"rate":"10-30","effect":"Fever"},{"rate":"5-20","effect":"Irritability"},{"rate":"5-15","effect":"Drowsiness"},{"rate":"5-10","effect":"Loss of appetite"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This pentavalent vaccine contains inactivated toxoids (diphtheria and tetanus), acellular pertussis antigens, recombinant hepatitis B surface antigen, and inactivated poliovirus particles. Upon intramuscular injection, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory B cells against all five pathogens. This provides immunization against these five serious infectious diseases in a single formulation.","oneSentence":"DTPa-HBV-IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:07.996Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children"}]},"trialDetails":[{"nctId":"NCT00463437","phase":"PHASE3","title":"Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-04-25","conditions":"Hepatitis B, Acellular Pertussis, Tetanus","enrollment":1437},{"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":"NCT01457508","phase":"PHASE3","title":"Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1999-01","conditions":"Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib)","enrollment":440},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"DTPa-HBV-IPV (Infanrix penta™)","genericName":"DTPa-HBV-IPV (Infanrix penta™)","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"DTPa-HBV-IPV is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis. Used for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}