{"id":"infanrix-ipv-hib","safety":{"commonSideEffects":[{"rate":"10-50%","effect":"Injection site pain, redness, or swelling"},{"rate":"10-30%","effect":"Fever"},{"rate":"10-40%","effect":"Irritability or fussiness"},{"rate":"5-20%","effect":"Drowsiness"},{"rate":"5-15%","effect":"Loss of appetite"}]},"_chembl":{"chemblId":"CHEMBL6068350","moleculeType":"Vaccine component"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated toxoids of diphtheria and tetanus, acellular pertussis antigens, inactivated poliovirus particles, and Haemophilus influenzae type b conjugate antigen. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory cells against these five pathogens.","oneSentence":"Infanrix-IPV/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:33:17.299Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children"}]},"trialDetails":[{"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":"NCT00505063","phase":"PHASE2","title":"Prospective Trial of Vaccine Responses in Childhood Cancer Survivors","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2007-07-10","conditions":"Childhood Cancer, Multiple Diseases","enrollment":76},{"nctId":"NCT05951725","phase":"PHASE3","title":"A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)","status":"ACTIVE_NOT_RECRUITING","sponsor":"CanSino Biologics Inc.","startDate":"2023-08-11","conditions":"Diphtheria, Tetanus and Acellular Pertussis","enrollment":2520},{"nctId":"NCT04535037","phase":"PHASE4","title":"A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-05-26","conditions":"Diphtheria","enrollment":500},{"nctId":"NCT06344065","phase":"PHASE3","title":"Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants","status":"RECRUITING","sponsor":"Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd","startDate":"2023-12-21","conditions":"Healthy Volunteers","enrollment":1584},{"nctId":"NCT06333275","phase":"","title":"Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy","status":"RECRUITING","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2023-11-14","conditions":"Vaccine Immunity in CAR-T Cell Therapy Recipients","enrollment":80},{"nctId":"NCT03530124","phase":"PHASE4","title":"Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines","status":"COMPLETED","sponsor":"Duke University","startDate":"2018-07-17","conditions":"Apnea, Apnea Neonatal, Prematurity","enrollment":223},{"nctId":"NCT06213506","phase":"PHASE2","title":"A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2024-01-15","conditions":"Salmonella Infections","enrollment":516},{"nctId":"NCT06184542","phase":"PHASE1","title":"Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine","status":"RECRUITING","sponsor":"Institute of Medical Biology, Chinese Academy of Medical Sciences","startDate":"2023-12-23","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":460},{"nctId":"NCT04099303","phase":"PHASE1","title":"Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .","status":"COMPLETED","sponsor":"CanSino Biologics Inc.","startDate":"2020-04-28","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":400},{"nctId":"NCT01129362","phase":"","title":"Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2010-02-08","conditions":"Pertussis","enrollment":1195},{"nctId":"NCT02482636","phase":"PHASE2","title":"Baby Vaccine Study (Sched3)","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2015-08","conditions":"Infectious Diseases","enrollment":189},{"nctId":"NCT01358825","phase":"PHASE4","title":"Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-05-30","conditions":"Tetanus, Poliomyelitis, Haemophilus Influenzae Type b","enrollment":58},{"nctId":"NCT01144663","phase":"PHASE3","title":"Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-01","conditions":"Infections, Meningococcal, Meningococcal Vaccines","enrollment":2095},{"nctId":"NCT01896596","phase":"PHASE4","title":"Hepatitis B Vaccination in Infants","status":"COMPLETED","sponsor":"Public Health England","startDate":"2013-07","conditions":"Meningococcal Disease, Pneumococcal Disease, Haemophilus Influenzae Serotype b Disease","enrollment":300},{"nctId":"NCT02173704","phase":"PHASE3","title":"Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-09-11","conditions":"Meningococcal Disease, Infections, Meningococcal","enrollment":225},{"nctId":"NCT01453998","phase":"PHASE2","title":"Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-10-14","conditions":"Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b","enrollment":657},{"nctId":"NCT00454987","phase":"PHASE4","title":"Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-05-16","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis, Neisseria Meningitidis-Haemophilus Influenzae Type b Vaccine","enrollment":288},{"nctId":"NCT01171989","phase":"PHASE2","title":"Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-08-18","conditions":"Tetanus, Diphtheria, Haemophilus Influenzae Type b","enrollment":391},{"nctId":"NCT01577732","phase":"PHASE3","title":"Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-12-08","conditions":"Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus","enrollment":321},{"nctId":"NCT00489554","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-07-03","conditions":"Infections, Streptococcal, Streptococcus Pneumoniae Vaccines","enrollment":230},{"nctId":"NCT00352963","phase":"PHASE3","title":"Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-09-30","conditions":"Poliomyelitis, Tetanus, Acellular Pertussis","enrollment":480},{"nctId":"NCT00609492","phase":"PHASE3","title":"Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-01-03","conditions":"Infections, Streptococcal, Streptococcus Pneumoniae Vaccines","enrollment":245},{"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":"NCT01353703","phase":"PHASE3","title":"Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-04-16","conditions":"Poliomyelitis, Tetanus, Acellular Pertussis","enrollment":224},{"nctId":"NCT01153841","phase":"PHASE3","title":"Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-02-17","conditions":"Infections, Streptococcal, Streptococcus Pneumoniae Vaccines","enrollment":300},{"nctId":"NCT01309646","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-03-04","conditions":"Poliomyelitis, Tetanus, Acellular Pertussis","enrollment":454},{"nctId":"NCT00753649","phase":"PHASE4","title":"Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-09-23","conditions":"Hepatitis B, Tetanus, Poliomyelitis","enrollment":224},{"nctId":"NCT02858440","phase":"PHASE3","title":"A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-09-13","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":235},{"nctId":"NCT00466947","phase":"PHASE3","title":"COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-06-28","conditions":"Infections, Streptococcal","enrollment":23802},{"nctId":"NCT00652951","phase":"PHASE3","title":"Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-04-01","conditions":"Infections, Streptococcal","enrollment":780},{"nctId":"NCT00370396","phase":"PHASE3","title":"Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-25","conditions":"Infections, Streptococcal","enrollment":1200},{"nctId":"NCT01204658","phase":"PHASE2","title":"Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-09-27","conditions":"Infections, Streptococcal","enrollment":576},{"nctId":"NCT01235949","phase":"PHASE4","title":"Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-11-12","conditions":"Infections, Streptococcal","enrollment":850},{"nctId":"NCT01480258","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-11-23","conditions":"Bacterial Infections, Virus Diseases","enrollment":1315},{"nctId":"NCT01003418","phase":"PHASE2","title":"Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2009-11-17","conditions":"Influenza","enrollment":8},{"nctId":"NCT01323647","phase":"PHASE3","title":"Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-04-25","conditions":"Poliomyelitis","enrollment":957},{"nctId":"NCT00496015","phase":"PHASE3","title":"Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-07-02","conditions":"Infections, Streptococcal","enrollment":750},{"nctId":"NCT00345358","phase":"PHASE3","title":"Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-18","conditions":"Infections, Streptococcal","enrollment":600},{"nctId":"NCT00513409","phase":"PHASE2","title":"Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-08-22","conditions":"Infections, Streptococcal","enrollment":163},{"nctId":"NCT00390910","phase":"PHASE3","title":"Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-10-01","conditions":"Infections, Streptococcal","enrollment":286},{"nctId":"NCT02002156","phase":"PHASE4","title":"A Study of the Interaction Between BCG And MenC Immunisation: BAM","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2014-06-20","conditions":"BCG Infection, Reaction - Vaccine, Immune Response","enrollment":28},{"nctId":"NCT01119625","phase":"PHASE3","title":"Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-12","conditions":"Infections, Streptococcal","enrollment":238},{"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":"NCT00586612","phase":"PHASE3","title":"Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-12-01","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":313},{"nctId":"NCT00129116","phase":"PHASE2","title":"3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-03-01","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":388},{"nctId":"NCT01248884","phase":"PHASE2","title":"Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-12-09","conditions":"Tetanus, Poliomyelitis, Hepatitis B","enrollment":721},{"nctId":"NCT01138098","phase":"PHASE4","title":"Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-07","conditions":"Hepatitis B","enrollment":185},{"nctId":"NCT00808444","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-01-05","conditions":"Infections, Streptococcal","enrollment":466},{"nctId":"NCT00307034","phase":"PHASE3","title":"Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-01-01","conditions":"Infections, Streptococcal","enrollment":351},{"nctId":"NCT00533507","phase":"PHASE3","title":"Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-09-18","conditions":"Infections, Rotavirus","enrollment":230},{"nctId":"NCT00196976","phase":"PHASE2","title":"Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-03-24","conditions":"Infections, Meningococcal","enrollment":461},{"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":"NCT00627458","phase":"PHASE2","title":"Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-01","conditions":"Acellular Pertussis, Diphtheria, Poliomyelitis","enrollment":403},{"nctId":"NCT01086423","phase":"PHASE3","title":"Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-03-01","conditions":"Tetanus, Poliomyelitis, Acellular Pertussis","enrollment":985},{"nctId":"NCT00325143","phase":"PHASE3","title":"Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-12-01","conditions":"Haemophilus Influenzae Type b, Diphtheria, Tetanus","enrollment":702},{"nctId":"NCT00964028","phase":"PHASE3","title":"Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-12-01","conditions":"Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria","enrollment":50},{"nctId":"NCT01449812","phase":"PHASE3","title":"Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-10-01","conditions":"Acellular Pertussis, Tetanus, Diphtheria","enrollment":831},{"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":"NCT00891176","phase":"PHASE3","title":"Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-05-14","conditions":"Neisseria Meningitidis, Haemophilus Influenzae Type b","enrollment":582},{"nctId":"NCT03128489","phase":"PHASE3","title":"Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2017-12-01","conditions":"Diphtheria, Acellular Pertussis, Haemophilus Influenzae Type b","enrollment":""},{"nctId":"NCT01457495","phase":"PHASE2","title":"Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"1998-09","conditions":"Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib)","enrollment":312},{"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":"NCT00289796","phase":"PHASE2","title":"Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2004-07","conditions":"Hepatitis B","enrollment":121},{"nctId":"NCT00376779","phase":"PHASE2","title":"Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-10","conditions":"Acellular Pertussis, Tetanus, Diphtheria","enrollment":450},{"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},{"nctId":"NCT00338351","phase":"PHASE2","title":"Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04","conditions":"Hepatitis A","enrollment":240},{"nctId":"NCT00258700","phase":"PHASE3","title":"Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2005-02","conditions":"Haemophilus Influenzae Type b, Neisseria Meningitidis","enrollment":478},{"nctId":"NCT00366366","phase":"PHASE3","title":"To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2001-09","conditions":"Hepatitis B","enrollment":150},{"nctId":"NCT00879827","phase":"PHASE3","title":"Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2000-09","conditions":"Diphtheria, Poliomyelitis, Hepatitis B","enrollment":60},{"nctId":"NCT01457560","phase":"PHASE3","title":"Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2000-02","conditions":"Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b","enrollment":80},{"nctId":"NCT01457547","phase":"PHASE4","title":"Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-10","conditions":"Hepatitis B, Poliomyelitis, Diphtheria","enrollment":494},{"nctId":"NCT00343421","phase":"PHASE3","title":"Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-07","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":588},{"nctId":"NCT00654901","phase":"PHASE3","title":"Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-03","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":881},{"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":"NCT00804284","phase":"","title":"Database Surveillance Safety Study of PENTACEL® Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2008-09","conditions":"Diphtheria, Tetanus, Pertussis","enrollment":62538},{"nctId":"NCT00287092","phase":"PHASE3","title":"Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-02","conditions":"Pertussis, Diphtheria, Tetanus","enrollment":807},{"nctId":"NCT00355654","phase":"PHASE3","title":"Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-09","conditions":"Infant, Healthy","enrollment":847},{"nctId":"NCT01444781","phase":"PHASE3","title":"Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2011-09","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":1106},{"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":"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":"NCT00294294","phase":"PHASE4","title":"Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa","status":"COMPLETED","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","startDate":"2005-05","conditions":"Vaccines, Pneumococcal, Infant, Fever, Chemically Induced","enrollment":300},{"nctId":"NCT00169728","phase":"PHASE3","title":"Vaccination of Children Following Allogeneic Stem Cell Transplantation","status":"COMPLETED","sponsor":"Heinrich-Heine University, Duesseldorf","startDate":"2003-09","conditions":"Allogeneic Haematopoietic Stem Cell Transplantation","enrollment":53},{"nctId":"NCT00662870","phase":"PHASE3","title":"Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine","status":"COMPLETED","sponsor":"Sanofi","startDate":"2001-05","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":1941},{"nctId":"NCT01105559","phase":"","title":"Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-04","conditions":"Diphtheria, Tetanus, Whooping Cough","enrollment":455},{"nctId":"NCT00355121","phase":"PHASE2","title":"Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®","status":"COMPLETED","sponsor":"Sanofi","startDate":"2006-10","conditions":"Meningococcal Meningitis, Tetanus, Diphtheria","enrollment":882},{"nctId":"NCT00990080","phase":"PHASE3","title":"Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age","status":"COMPLETED","sponsor":"Dalhousie University","startDate":"2010-05","conditions":"Infant Immunizations","enrollment":253}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"JAUNDICE"},{"count":2,"reaction":"PNEUMONIA"},{"count":2,"reaction":"PYREXIA"},{"count":1,"reaction":"ACUTE SINUSITIS"},{"count":1,"reaction":"ADVERSE EVENT FOLLOWING IMMUNISATION"},{"count":1,"reaction":"ANAEMIA"},{"count":1,"reaction":"ATTENTION DEFICIT HYPERACTIVITY DISORDER"},{"count":1,"reaction":"BODY TEMPERATURE INCREASED"},{"count":1,"reaction":"CONJUNCTIVITIS"},{"count":1,"reaction":"CRYING"}],"_approvalHistory":[],"publicationCount":10,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["DTPa-combined vaccine"],"phase":"marketed","status":"active","brandName":"Infanrix-IPV/Hib","genericName":"Infanrix-IPV/Hib","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Biologic","firstApprovalDate":"","aiSummary":"Infanrix-IPV/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b. Used for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}