{"id":"act-hib","safety":{"commonSideEffects":[{"rate":null,"effect":"Local injection site reactions (pain, erythema, swelling)"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Irritability"},{"rate":null,"effect":"Drowsiness"}]},"_chembl":{"chemblId":"CHEMBL6068504","moleculeType":"Small molecule","molecularWeight":"545.72"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains the polyribosylribitol phosphate (PRP) capsular polysaccharide of Haemophilus influenzae type b conjugated to a protein carrier, which enhances immunogenicity and promotes T-cell dependent B-cell responses. This conjugation strategy improves antibody production and immunological memory compared to unconjugated polysaccharide vaccines, providing protection against invasive Hib disease including meningitis, bacteremia, and epiglottitis.","oneSentence":"Act-HIB is a conjugate vaccine that stimulates immune response against Haemophilus influenzae type b (Hib) by linking the bacterial polysaccharide capsule to a protein carrier.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:59:06.070Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"nctId":"NCT02140047","phase":"PHASE2","title":"Exploratory Clinical Study of MT-2301","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2014-04","conditions":"Haemophilus Influenza Type b","enrollment":154},{"nctId":"NCT06975878","phase":"PHASE3","title":"Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2025-05-22","conditions":"Pneumococcal Immunization, Healthy Volunteers","enrollment":1092},{"nctId":"NCT06736041","phase":"PHASE3","title":"Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-12-18","conditions":"Pneumococcal Immunization","enrollment":1714},{"nctId":"NCT06793826","phase":"","title":"Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2025-01-17","conditions":"Hepatitis B, Haemophilus Influenzae Type b Immunisation","enrollment":713},{"nctId":"NCT05794230","phase":"PHASE3","title":"Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2023-03-27","conditions":"Meningococcal Immunisation, Healthy Volunteers","enrollment":1528},{"nctId":"NCT06647407","phase":"PHASE1, PHASE2","title":"Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2024-11-05","conditions":"Meningococcal Immunization, Healthy Volunteers","enrollment":750},{"nctId":"NCT02992925","phase":"PHASE3","title":"Phase 3 Study of BK1310 in Healthy Infants","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2016-11","conditions":"Immunization; Infection","enrollment":370},{"nctId":"NCT03891758","phase":"PHASE3","title":"Confirmatory Study of BK1310 in Healthy Infants","status":"COMPLETED","sponsor":"Tanabe Pharma Corporation","startDate":"2019-04-01","conditions":"Tetanus, Diphtheria, Pertussis","enrollment":267},{"nctId":"NCT03673462","phase":"PHASE3","title":"Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-09-17","conditions":"Healthy Volunteers (Meningococcal Infection)","enrollment":2797},{"nctId":"NCT03630705","phase":"PHASE3","title":"Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2018-10-17","conditions":"Healthy Volunteers (Meningococcal Infection)","enrollment":525},{"nctId":"NCT03893448","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-06-19","conditions":"Pneumococcal Infections, Pneumococcal Vaccines","enrollment":1720},{"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":"NCT02697474","phase":"PHASE3","title":"Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2016-02","conditions":"Hepatitis B","enrollment":150},{"nctId":"NCT02817451","phase":"PHASE3","title":"DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2016-07-14","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":53},{"nctId":"NCT02428491","phase":"PHASE3","title":"Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-04-20","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":354},{"nctId":"NCT03207750","phase":"PHASE3","title":"This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-09-14","conditions":"Rotavirus Infection, Rotavirus Vaccines","enrollment":1280},{"nctId":"NCT04000932","phase":"PHASE3","title":"Platelet Rich Plasma in Carpal Tunnel Syndrome","status":"UNKNOWN","sponsor":"Baskent University","startDate":"2018-07-15","conditions":"Carpal Tunnel Syndrome","enrollment":84},{"nctId":"NCT01098474","phase":"PHASE2","title":"Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-07","conditions":"Tuberculosis","enrollment":301},{"nctId":"NCT00614614","phase":"PHASE3","title":"Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-13","conditions":"Infections, Meningococcal","enrollment":1558},{"nctId":"NCT00127855","phase":"PHASE2","title":"Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-03-01","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":409},{"nctId":"NCT00129129","phase":"PHASE2","title":"Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-08-01","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":756},{"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":"NCT01000974","phase":"PHASE3","title":"Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-18","conditions":"Haemophilus Influenzae Type b","enrollment":4003},{"nctId":"NCT02610348","phase":"NA","title":"Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2015-11","conditions":"Hepatitis B","enrollment":122},{"nctId":"NCT02094833","phase":"PHASE3","title":"DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2014-03","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":310},{"nctId":"NCT00323622","phase":"PHASE2","title":"Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-04","conditions":"Malaria","enrollment":1737},{"nctId":"NCT00334607","phase":"PHASE3","title":"Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-06","conditions":"Infections, Rotavirus","enrollment":484},{"nctId":"NCT00831753","phase":"PHASE3","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-05","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":263},{"nctId":"NCT00771849","phase":"PHASE2","title":"Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2003-08","conditions":"Meningitis, Meningococcemia","enrollment":103},{"nctId":"NCT00802867","phase":"PHASE4","title":"Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2004-02","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":989},{"nctId":"NCT02560272","phase":"PHASE3","title":"Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried","status":"UNKNOWN","sponsor":"Beijing Minhai Biotechnology Co., Ltd","startDate":"2014-09","conditions":"Haemophilus Influenzae Type b Infections","enrollment":1560},{"nctId":"NCT00315055","phase":"PHASE3","title":"Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":310},{"nctId":"NCT00404651","phase":"PHASE3","title":"Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-11","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":1189},{"nctId":"NCT00362336","phase":"PHASE3","title":"Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-08","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":622},{"nctId":"NCT00401531","phase":"PHASE3","title":"Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-10","conditions":"Hepatitis B, Polio, Diphtheria","enrollment":412},{"nctId":"NCT00474526","phase":"PHASE3","title":"A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants","status":"COMPLETED","sponsor":"Novartis Vaccines","startDate":"2007-03","conditions":"Meningitis, Meningococcal","enrollment":4545},{"nctId":"NCT00255047","phase":"PHASE3","title":"Safety and Immune Response of Different Pediatric Combination Vaccines.","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2005-11","conditions":"Diphtheria, Polio, Pertussis","enrollment":2167},{"nctId":"NCT00831311","phase":"PHASE2","title":"Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2004-10","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":624},{"nctId":"NCT01732198","phase":"PHASE2","title":"A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers","status":"UNKNOWN","sponsor":"Nuron Biotech Inc.","startDate":"2013-03","conditions":"Infectious Disease","enrollment":220},{"nctId":"NCT01578070","phase":"PHASE1, PHASE2","title":"Single-center Study Evaluating the Safety and Efficacy of Viscogel® as Adjuvant in Act-HIB® Vaccine","status":"COMPLETED","sponsor":"Viscogel AB","startDate":"2012-03","conditions":"Healthy","enrollment":130},{"nctId":"NCT01491087","phase":"PHASE4","title":"Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2011-12","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":900},{"nctId":"NCT00303316","phase":"PHASE3","title":"Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-02","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":458},{"nctId":"NCT00772928","phase":"PHASE3","title":"Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™","status":"COMPLETED","sponsor":"Sanofi","startDate":"2003-10","conditions":"Diphtheria, Tetanus, Haemophilus Infection","enrollment":1167},{"nctId":"NCT01226953","phase":"PHASE3","title":"Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants","status":"COMPLETED","sponsor":"Novartis Vaccines","startDate":"2010-10","conditions":"Haemophilus Influenzae Type b (Hib) Infection","enrollment":660}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":37,"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":"Act-HIB®","genericName":"Act-HIB®","companyName":"Beijing Minhai Biotechnology Co., Ltd","companyId":"beijing-minhai-biotechnology-co-ltd","modality":"Biologic","firstApprovalDate":"","aiSummary":"Act-HIB is a conjugate vaccine that stimulates immune response against Haemophilus influenzae type b (Hib) by linking the bacterial polysaccharide capsule to a protein carrier. Used for Prevention of invasive disease caused by Haemophilus influenzae type b 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}}