{"id":"pedvaxhib","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (erythema, swelling, induration)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Drowsiness"}]},"_chembl":null,"_dailymed":{"setId":"9dff46c6-4b15-4d10-aca6-d5ef3735a530","title":"PEDVAXHIB (HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL PROTEIN CONJUGATE)) INJECTION, SUSPENSION [MERCK SHARP & DOHME LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains the polyribosylribitol phosphate (PRP) capsular polysaccharide of Haemophilus influenzae type b conjugated to meningococcal outer membrane protein complex (OMPC). This conjugation enhances immunogenicity by converting the T-cell-independent polysaccharide antigen into a T-cell-dependent antigen, enabling robust antibody production and immunological memory against Hib infection.","oneSentence":"PedvaxHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by presenting the bacterial polysaccharide capsule linked to a protein carrier.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:00:05.792Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT00855855","phase":"","title":"Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2009-02","conditions":"Haemophilus Infections, Diphtheria, Tetanus","enrollment":20830},{"nctId":"NCT01545375","phase":"PHASE2","title":"Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-05-21","conditions":"Infections, Streptococcal","enrollment":1806},{"nctId":"NCT01978093","phase":"PHASE3","title":"Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-02-01","conditions":"Neisseria Meningitidis, Haemophilus Influenzae Type b","enrollment":600},{"nctId":"NCT00134719","phase":"PHASE2","title":"Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-04-11","conditions":"Neisseria Meningitidis, Haemophilus Influenzae Type b","enrollment":1104},{"nctId":"NCT00362427","phase":"PHASE2","title":"Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Diphtheria, Pertussis, Polio","enrollment":460}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":49,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Comparator","Monovalent Hib conjugate vaccine."],"phase":"marketed","status":"active","brandName":"PedvaxHIB®","genericName":"PedvaxHIB®","companyName":"GlaxoSmithKline","companyId":"glaxosmithkline","modality":"Biologic","firstApprovalDate":"","aiSummary":"PedvaxHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by presenting the bacterial polysaccharide capsule linked to a protein carrier. Used for Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}