{"id":"comparator-pedvaxhib","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site erythema"},{"rate":null,"effect":"Injection site swelling"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Drowsiness"}]},"_chembl":{"chemblId":"CHEMBL3983509","moleculeType":"Small molecule","molecularWeight":"434.92"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Comparator: PedvaxHIB™","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:21:59.756336+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:22:14.869261+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:22:06.221609+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Comparator: PedvaxHIB™","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:22:06.853516+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3983509/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:22:07.595274+00:00"}},"_dailymed":null,"aiSummary":"PedvaxHIB is a vaccine used to prevent Haemophilus influenzae type b infections. It is a small molecule vaccine, specifically a conjugate vaccine, used in combination with other vaccines to protect against various bacterial and viral infections.","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 polysaccharide into a T-cell-dependent antigen, enabling robust antibody responses and immunological memory in infants and young children. The resulting antibodies provide protection against invasive Hib disease including meningitis, bacteremia, and epiglottitis.","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":"2026-03-28T00:19:48.607Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:22:14.869660+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"name":"Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT01337167","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-04-19","conditions":"Bacterial Infections, Virus Diseases","enrollment":1473},{"nctId":"NCT00289913","phase":"PHASE4","title":"Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-04","conditions":"Hepatitis A Virus","enrollment":1274},{"nctId":"NCT00441012","phase":"PHASE3","title":"Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-12","conditions":"Haemophilus Influenzae Type B, Hepatitis B","enrollment":546}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL3983509"},"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study","visit in all treatment groups in the study."],"phase":"marketed","status":"active","brandName":"Comparator: PedvaxHIB™","genericName":"Comparator: PedvaxHIB™","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T05:22:14.869660+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}