{"id":"hib","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"Reported 11 times"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"Reported 8 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 7 times"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"Reported 7 times"},{"date":"","signal":"FOETAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"MALAISE","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"Reported 5 times"}],"drugInteractions":[{"drug":"Ampicillin","action":"Avoid","effect":"Decreased efficacy of Hib vaccine"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Immunosuppressive agents","action":"Monitor","effect":"Decreased antibody response"},{"drug":"Live vaccines","action":"Avoid","effect":"Interference with vaccine-induced immune response"},{"drug":"Other vaccines","action":"Avoid","effect":"Interference with vaccine-induced immune response"}],"commonSideEffects":[{"effect":"≥ 1 Apneic Event","drugRate":"23.4%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":107,"totalAffected":25,"trialsReporting":1},{"effect":"Severe Cardiorespiratory Event","drugRate":"17.9%","organSystem":"Cardiac disorders","placeboRate":"","totalAtRisk":39,"totalAffected":7,"trialsReporting":1},{"effect":"Upper respiratory tract infection","drugRate":"3.2%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":4,"trialsReporting":1},{"effect":"Pyrexia","drugRate":"2.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":125,"totalAffected":3,"trialsReporting":1},{"effect":"Cough","drugRate":"2.4%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":3,"trialsReporting":1},{"effect":"Erythema","drugRate":"2.4%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":3,"trialsReporting":1},{"effect":"Nasopharyngitis","drugRate":"1.6%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":2,"trialsReporting":1},{"effect":"Erythema (REDNESS)","drugRate":"0.8%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":1,"trialsReporting":1},{"effect":"Diarrhoea","drugRate":"0.8%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":1,"trialsReporting":1},{"effect":"Asthma","drugRate":"0.8%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":1,"trialsReporting":1},{"effect":"Pyrexia (FEVER)","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Swelling (SWELLING)","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Tenderness (TENDERNESS)","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Decreased appetite (DECREASED APPETITE)","drugRate":"0.0%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Rhinorrhoea","drugRate":"0.0%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Fatigue (FATIGUE)","drugRate":"0.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Dermatitis allergic","drugRate":"0.0%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Rash","drugRate":"0.0%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Leukopenia","drugRate":"0.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Lymphadenitis","drugRate":"0.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Intussusception","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Diarrhoea (DIARRHEA)","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Vomiting (VOMITING)","drugRate":"0.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Hepatic function abnormal","drugRate":"0.0%","organSystem":"Hepatobiliary disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Bronchitis","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Laryngitis","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Pneumonia","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Viral rash","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Hand-foot-and -mouth disease","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Febrile convulsion","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Hypersomnia (INCREASED SLEEP)","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Headache (HEADACHE)","drugRate":"0.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Irritability (IRRITABILITY)","drugRate":"0.0%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Thermal burn","drugRate":"0.0%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Myalgia (MUSCLE PAIN)","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1},{"effect":"Arthralgia (JOINT PAIN)","drugRate":"0.0%","organSystem":"Musculoskeletal and connective tissue disorders","placeboRate":"","totalAtRisk":125,"totalAffected":0,"trialsReporting":1}],"contraindications":["A severe allergic reaction (eg, anaphylaxis) after a previous dose or to a vaccine component","Infant age < 6 weeks"],"specialPopulations":{"Pregnancy":"No information available","Geriatric use":"The haemophilus b conjugate vaccine (tetanus toxoid conjugate) is not for use in adult or geriatric patients","Paediatric use":"Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ActHIB®, HibTITER®, or PedvaxHIB® in children 2 months to 5 years of age. However, safety and efficacy have not been established in children 6 years of age and older and children younger than 2 months of age. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the Hiberix® vaccine in children 15 months to 4 years of age. However, safety and efficacy have not been established in children 5 years of age and older and children younger than 15 months of age.","Renal impairment":"No information available","Hepatic impairment":"No information available"},"seriousAdverseEvents":[{"event":"Pneumonia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"5.6%"},{"event":"Hospital readmission for tachypnea","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"0.9%"},{"event":"Hospital readmission for retinopathy of prematurity","detail":"Eye disorders. 1 trial(s).","severity":"serious","incidence":"0.9%"},{"event":"Respiratory decompensation and hypotension following elective surgery","detail":"Surgical and medical procedures. 1 trial(s).","severity":"serious","incidence":"0.9%"},{"event":"Lower respiratory tract infection bacterial","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.8%"},{"event":"Asthma","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"0.8%"},{"event":"Pyrexia","detail":"General disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Upper respiratory tract infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Lymphadenitis","detail":"Blood and lymphatic system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Otitis media","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Febrile convulsion","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Toxic encephalopathy","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Sleep apnoea syndrome","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"_whoEML":{"listed":true,"source":"WHO EML"},"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T21:58:18.948149+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T21:58:06.305986+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T21:58:26.444135+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:27.937321+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:58:11.353754+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:58:12.326220+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:27.937245+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:27.937241+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T10:49:30.714539+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:27.937213+00:00"}},"dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41f8716d-a970-40cd-a29d-69dafc97def8","setid":"41f8716d-a970-40cd-a29d-69dafc97def8","title":"ECO BANDAGE HIBISCUS (BENZETHONIUM CHLORIDE) LIQUID [ECO BANDAGE LLC]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=26151cf4-0fee-4a42-92fd-4d7b9cef8381","setid":"26151cf4-0fee-4a42-92fd-4d7b9cef8381","title":"SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 FAIR SHIRAKABA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 125 FAIR ASTERID (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 215 LIGHT BUNA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 225 LIGHT MAGNOLIA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 235 LIGHT HIBA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 315 MEDIUM MATSU (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 325 MEDIUM KEYAKI (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 335 MEDIUM KATSURA (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 415 TAN KWANZAN (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 425 TAN UME (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 515 DEEP TSUBAKI (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 525 DEEP KUROMOJI (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=745ff8df-1618-4b76-9aa1-6f42752c0dda","setid":"745ff8df-1618-4b76-9aa1-6f42752c0dda","title":"HIBERIX (HAEMOPHILUS B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)) KIT [GLAXOSMITHKLINE BIOLOGICALS SA]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=288c5840-e988-e269-e063-6394a90a0529","setid":"288c5840-e988-e269-e063-6394a90a0529","title":"SECRET TROPICAL HIBISCUS CLEAR (ALUMINUM ZIRCONIUM OCTACHLOROHYDREX GLY) GEL [THE PROCTER & GAMBLE MANUFACTURING COMPANY]"},{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f5de3c24-3dcd-686f-e053-2995a90a6b77","setid":"f5de3c24-3dcd-686f-e053-2995a90a6b77","title":"SECRET WEIGHTLESS DRY TROPICAL HIBISCUS PLUS ARGAN OIL (ALUMINUM CHLOROHYDRATE) AEROSOL, SPRAY [THE PROCTER & GAMBLE MANUFACTURING COMPANY]"}],"offLabel":[],"timeline":[],"_dailymed":{"setId":"41f8716d-a970-40cd-a29d-69dafc97def8","title":"ECO BANDAGE HIBISCUS (BENZETHONIUM CHLORIDE) LIQUID [ECO BANDAGE LLC]","labeler":""},"aiSummary":"Pfizer's Hib vaccine holds a significant market position with 51 approved indications, though it is not among the world's best-selling drugs. The vaccine faces competition from alternatives like Rifampin, Rifadin IV, Rimactane, ActHIB, and Haemophilus b conjugate (prp-omp) vaccine, which also target Haemophilus influenzae prophylaxis. A key risk is the requirement for a PD-L1 companion diagnostic for several of its indications, potentially limiting its market reach. Despite the competitive landscape, the robust number of approved indications suggests a strong pipeline outlook for the vaccine.","brandName":"Hib","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Haemophilus influenzae type b","novelty":"me-too","modality":"vaccine","drugClass":"bacterial vaccine","explanation":"Haemophilus influenzae is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacteria are mesophilic and grow best at temperatures between 35 and 37 °C. This bacterium is responsible for causing Haemophilus influenzae type b disease in children.","oneSentence":"Hib is a bacterial vaccine that stimulates an immune response against Haemophilus influenzae type b.","technicalDetail":"Hib works by exposing the body to a weakened form of Haemophilus influenzae type b, stimulating an immune response and producing antibodies against the bacteria. This leads to the prevention of the disease in children."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Haemophilus influenzae","extract":"Haemophilus influenzae is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacteria are mesophilic and grow best at temperatures between 35 and 37 °C."},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$21.2B","peakSalesEstimate":"$21.2B"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=hib","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=hib","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/hib","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":4,"lastValidatedAt":"2026-04-20T10:49:31.434095+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Rifampin","company":"Rifadin, Rimactane","advantage":"Competes with Hib (Hiberix) for Haemophilus influenzae Prophylaxis"},{"name":"Rifadin IV","company":"Rifadin, Rimactane","advantage":"Competes with Hib (Hiberix) for Haemophilus influenzae Prophylaxis"},{"name":"Rimactane","company":"Rifadin, Rimactane","advantage":"Competes with Hib (Hiberix) for Haemophilus influenzae Prophylaxis"},{"name":"ActHIB","company":"ActHIB","advantage":"Competes with Hib (Hiberix) for Haemophilus influenzae Prophylaxis"},{"name":"Haemophilus b conjugate (prp-omp) vaccine","company":"Haemophilus b conjugate (prp-omp) vaccine","advantage":"Competes with Hib (Hiberix) for Haemophilus influenzae Prophylaxis"},{"name":"Pentacel","company":"Pentacel","advantage":"Competes with Hib (Hiberix) for Active immunization against diphtheria, tetanus, pertussis and poliomyelitis"},{"name":"Pediarix","company":"Pediarix","advantage":"Competes with Hib (Hiberix) for Diphtheria, hepatitis B, pertussis, polio and tetanus prevention"},{"name":"Vaxelis","company":"Vaxelis","advantage":"Competes with Hib (Hiberix) for Diphtheria prophylaxis, Haemophilus influenzae type b prophylaxis"}],"genericName":"hib","indications":{"approved":[{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 6 weeks through 18 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 12 through 15 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 12 through 59 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 12 through 71 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 12 through 72 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 15 through 18 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 71 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 72 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 59 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 60 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 61 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 62 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 63 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 64 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 65 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 66 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 67 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 68 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 69 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 70 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 71 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 72 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 59 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 60 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 61 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 62 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 63 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 64 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 65 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 66 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 67 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 68 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 69 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 70 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 71 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 72 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 59 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 60 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 61 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 62 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 63 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 64 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 65 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 66 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 67 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 68 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 69 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 70 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 71 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 18 through 72 months of age","regulator":"FDA"},{"name":"Prevention of Haemophilus influenzae type b (Hib) disease caused by Haemophilus influenzae type b (Hib) in children 59 through 71 months of age","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"","name":"Hib","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"pubchemSID":"7888159"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":3701,"therapeuticAreas":["Immunology"],"_revenueScrapedAt":"2026-03-31 09:33:26.346658+00","biosimilarFilings":[],"recentPublications":[{"pmid":"41837957","title":"Costs of managing adverse reactions to hexavalent vaccines: Comparison of DT3aP-HBV-IPV/Hib and DT2aP-HBV-IPV-Hib in France and Spain.","authors":"Nikitas G, Mohy A, Duchenne M, Genovez V, Casabona G","journal":"Hum Vaccin Immunother","pubDate":"2026 Dec"},{"pmid":"41616649","title":"Preliminary safety evaluation of a diphtheria, tetanus, acellular component pertussis, Sabin inactivated poliovirus and Haemophilus influenzae type b combination vaccine (DTacP-sIPV/Hib).","authors":"Cai L, Fu Y, Li J, Wang X, Ma Y","journal":"Vaccine","pubDate":"2026 Mar 7"},{"pmid":"41600945","title":"Preclinical Study on Sabin Strain-Based DTaP-sIPV/Hib Pentavalent Vaccine: Evaluation of Repeated-Dose Toxicity and Immunogenicity.","authors":"Zhao T, Chu H, Ma Y, Gu Q, Gao N","journal":"Vaccines (Basel)","pubDate":"2025 Dec 25"},{"pmid":"41441664","title":"Disease and Economic Burden Averted by Hib Vaccination in 160 Countries: A Machine-Learning Analysis.","authors":"Zhou D, Chan S, Zhong Y, Xu Z, Wang J","journal":"Vaccines (Basel)","pubDate":"2025 Nov 27"},{"pmid":"41429065","title":"Ensuring structural integrity of Hib capsular polysaccharide in conjugate vaccine manufacturing by (1)H NMR and HPSEC-MALLS/RI.","authors":"Ma W, Yu Y, Zhu N, Zhang F, Zhang S","journal":"Vaccine","pubDate":"2026 Feb 6"},{"pmid":"41355361","title":"Reporting profile of adverse events following DTaP-IPV/Hib pentavalent vaccine: A 13-year real-world surveillance data analysis.","authors":"Zhang C, Liu X, Han L, Shen J","journal":"Hum Vaccin Immunother","pubDate":"2025 Dec"},{"pmid":"41245254","title":"Comparative safety evaluation of pentavalent (DTaP-IPV-Hib) and hexavalent (DTaP-IPV-Hib-HepB) vaccines in infants: a real-world analysis based on VAERS.","authors":"Wei Z, Li B, Jia HL","journal":"Front Cell Infect Microbiol","pubDate":"2025"},{"pmid":"41150382","title":"Preclinical Immunogenicity Evaluation of a DTacP-sIPV/Hib Combination Vaccine in Rodent Models Under Varying Formulations and Immunization Schedules.","authors":"Fu Y, Huang W, Cai L, Ma Y, Gu Q","journal":"Vaccines (Basel)","pubDate":"2025 Sep 23"},{"pmid":"40966760","title":"Emerging Invasive Haemophilus influenzae Type C Infection in a Hib-vaccinated Child: Implications for Surveillance.","authors":"Kasai S, Nagata M, Toyama Y, Inage E, Suzuki M","journal":"Pediatr Infect Dis J","pubDate":"2026 Feb 1"},{"pmid":"40333242","title":"Adverse Events Following Haemophilus influenzae Type b (Hib) Monovalent Vaccines in Zhejiang Province, China, from 2017 to 2023.","authors":"Pan X, Chen Y, Liang H, Shen L, Qi X","journal":"Vaccines (Basel)","pubDate":"2025 Mar 25"}],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[{"hr":"2.70","nctId":"NCT03530124","phase":"PHASE4","pValue":"0.0104","ciLower":"1.27","ciUpper":"5.73","endpoint":"Occurrence of Apnea","enrollment":223}],"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":9,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":""}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":2,"withResults":2},"validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T10:49:31.434095+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}