{"id":"daptacel","rwe":[{"pmid":"41704959","year":"2026","title":"Diphtheria-tetanus-acellular pertussis vaccine safety in children under 7 years: a post-marketing analysis of the U.S. vaccine adverse event reporting system.","finding":"","journal":"Frontiers in cellular and infection microbiology","studyType":"Clinical Study"},{"pmid":"27069343","year":"2016","title":"Quadracel: Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis in Children.","finding":"","journal":"P & T : a peer-reviewed journal for formulary management","studyType":"Clinical Study"},{"pmid":"26334944","year":"2015","title":"Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose.","finding":"","journal":"MMWR. Morbidity and mortality weekly report","studyType":"Clinical Study"},{"pmid":"19117896","year":"2009","title":"Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial.","finding":"","journal":"Pediatrics","studyType":"Clinical Study"},{"pmid":"12139185","year":"2002","title":"Food and Drug Administration approval of a fifth acellular pertussis vaccine for use among infants and young children--United States, 2002.","finding":"","journal":"MMWR. Morbidity and mortality weekly report","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Active","category":"status"},{"label":"Merck Sharp & Dohme LLC","category":"company"}],"phase":"marketed","safety":{"commonSideEffects":[{"effect":"Seizures","drugRate":"2.3%","severity":"common","organSystem":""},{"effect":"Whole limb swelling","drugRate":"0.39%","severity":"common","organSystem":""},{"effect":"Infantile spasms","drugRate":"0.39%","severity":"common","organSystem":""}],"seriousAdverseEvents":[{"effect":"Seizures","drugRate":"2.3%","severity":"serious"},{"effect":"Whole limb swelling with generalized symptoms","drugRate":"0.39%","severity":"serious"},{"effect":"Infantile spasms","drugRate":"0.39%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Merck Sharp & Dohme LLC","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DAPTACEL™","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:12:49.789901+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:12:56.089590+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DAPTACEL™","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:12:56.926718+00:00"}},"allNames":["daptacel™"],"offLabel":[],"synonyms":[],"timeline":[],"approvals":[],"ecosystem":[],"mechanism":{"modality":"Small Molecule","explanation":"","oneSentence":"","technicalDetail":"Daptacel is a small molecule vaccine that likely works by interacting with the immune system's dendritic cells, which then present antigens to T-cells, triggering an immune response and providing long-term protection against disease."},"commercial":{},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=daptacel%E2%84%A2","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=daptacel™","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:23:11.918428","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:12:59.100638+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"daptacel™","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05116241","phase":"PHASE2","title":"Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children","status":"COMPLETED","sponsor":"ILiAD Biotechnologies","startDate":"2021-11-11","conditions":["Bordetella Pertussis, Whooping Cough"],"enrollment":368,"completionDate":"2024-05-15"},{"nctId":"NCT02569879","phase":"","title":"Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-10-01","conditions":["Diphtheria","Acellular Pertussis","Tetanus","Aspergillosis, Allergic Bronchopulmonary","Diphtheria-Tetanus-acellular Pertussis Vaccines"],"enrollment":1,"completionDate":"2018-04-14"},{"nctId":"NCT04031846","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-09-04","conditions":["Pneumococcal Infections"],"enrollment":1184,"completionDate":"2021-08-05"},{"nctId":"NCT03942406","phase":"PHASE2","title":"Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults","status":"COMPLETED","sponsor":"ILiAD Biotechnologies","startDate":"2019-06-15","conditions":["Pertussis","Whooping Cough"],"enrollment":300,"completionDate":"2020-06-24"},{"nctId":"NCT01137435","phase":"PHASE4","title":"Post Marketing Surveillance for ADACEL™ in South Korea","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2010-06","conditions":["Diphtheria","Tetanus","Pertussis"],"enrollment":659,"completionDate":"2016-09"},{"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","Acellular Pertussis","Diphtheria","Hepatitis B","Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines"],"enrollment":58,"completionDate":"2011-07-15"},{"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,"completionDate":"2013-09-10"},{"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,"completionDate":"2007-10-12"},{"nctId":"NCT03035370","phase":"PHASE1","title":"Viaskin Pertussis Vaccine Trial","status":"COMPLETED","sponsor":"DBV Technologies","startDate":"2016-09-05","conditions":["Whooping Cough"],"enrollment":102,"completionDate":"2018-04-25"},{"nctId":"NCT02377349","phase":"PHASE4","title":"Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-10-14","conditions":["Diphtheria-Tetanus-acellular Pertussis Vaccines"],"enrollment":688,"completionDate":"2017-10-24"},{"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","Hepatitis B","Poliomyelitis","Acellular Pertussis","Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni"],"enrollment":391,"completionDate":"2010-12-03"},{"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","Poliomyelitis","Diphtheria","Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines"],"enrollment":321,"completionDate":"2013-04-09"},{"nctId":"NCT02798952","phase":"PHASE4","title":"A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-08-23","conditions":["Hepatitis B"],"enrollment":302,"completionDate":"2017-07-05"},{"nctId":"NCT02853929","phase":"PHASE4","title":"Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-09-19","conditions":["Diphtheria","Hepatitis B","Acellular Pertussis","Haemophilus Influenzae Type b","Tetanus","Poliomyelitis","Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines"],"enrollment":551,"completionDate":"2019-03-19"},{"nctId":"NCT00548171","phase":"PHASE4","title":"Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-11-05","conditions":["Acellular Pertussis","Tetanus","Diphtheria","Diphtheria-Tetanus-acellular Pertussis Vaccines"],"enrollment":203,"completionDate":"2008-04-30"},{"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","Hepatitis B","Diphtheria"],"enrollment":480,"completionDate":"2004-07-16"},{"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,"completionDate":"2009-03-30"},{"nctId":"NCT00835237","phase":"PHASE3","title":"Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-02-17","conditions":["Tetanus","Acellular Pertussis","Diphtheria","Diphtheria-Tetanus-acellular Pertussis Vaccines"],"enrollment":1332,"completionDate":"2009-10-15"},{"nctId":"NCT00970307","phase":"PHASE2","title":"Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-08-13","conditions":["Tetanus","Diphtheria","Haemophilus Influenzae Type b","Poliomyelitis","Acellular Pertussis","Hepatitis B","Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni"],"enrollment":421,"completionDate":"2010-01-27"},{"nctId":"NCT00908115","phase":"","title":"Post Market Surveillance for Infanrix™","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-08-01","conditions":["Diphtheria","Acellular Pertussis","Tetanus"],"enrollment":1258,"completionDate":"2008-06-23"},{"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","Poliomyelitis","Diphtheria","Streptococcus Pneumoniae Vaccines"],"enrollment":1437,"completionDate":"2008-06-14"},{"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,"completionDate":"2011-07-26"},{"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","Haemophilus Influenzae Type b","Diphtheria","Hepatitis B","Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines"],"enrollment":224,"completionDate":"2013-02-25"},{"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","Diphtheria","Haemophilus Influenzae Type b","Acellular Pertussis"],"enrollment":224,"completionDate":"2013-03-12"},{"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","Diphtheria","Haemophilus Influenzae Type b"],"enrollment":454,"completionDate":"2012-02-24"},{"nctId":"NCT02712177","phase":"","title":"Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization","status":"COMPLETED","sponsor":"CHU de Quebec-Universite Laval","startDate":"2008-08","conditions":["Meningococcal Infections"],"enrollment":4535,"completionDate":"2019-04"},{"nctId":"NCT01340898","phase":"PHASE3","title":"Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-01-27","conditions":["Meningococcal Infection"],"enrollment":753,"completionDate":"2015-10-19"},{"nctId":"NCT01345240","phase":"PHASE3","title":"Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-11-17","conditions":["Malaria","Malaria Vaccines"],"enrollment":705,"completionDate":"2017-02-09"},{"nctId":"NCT01616459","phase":"PHASE2","title":"Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-07-11","conditions":["Infections, Streptococcal"],"enrollment":953,"completionDate":"2014-01-22"},{"nctId":"NCT02422264","phase":"PHASE4","title":"Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-01-22","conditions":["Acellular Pertussis","Tetanus","Poliomyelitis","Diphtheria","Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines"],"enrollment":601,"completionDate":"2018-03-07"},{"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,"completionDate":"2010-12-01"},{"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,"completionDate":"2007-11-06"},{"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,"completionDate":"2012-10-01"},{"nctId":"NCT01341639","phase":"PHASE3","title":"Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)","status":"COMPLETED","sponsor":"MCM Vaccines B.V.","startDate":"2011-05-26","conditions":["Bacterial Infections","Virus Diseases"],"enrollment":1250,"completionDate":"2013-03-13"},{"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,"completionDate":"2013-10-09"},{"nctId":"NCT02526394","phase":"PHASE4","title":"Pertussis and Meningitis C Concomitant Vaccination in Adolescents","status":"COMPLETED","sponsor":"Public Health England","startDate":"2013-09","conditions":["Pertussis","Meningitis","Preventive Immunization; Meningitis","Immunization"],"enrollment":400,"completionDate":"2017-03-31"},{"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,"completionDate":"2010-11-25"},{"nctId":"NCT03188458","phase":"PHASE4","title":"Immunogenicity of a Single Dose of GSK Biologicals' Boostrix™ in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2018-05-29","conditions":["Diphtheria-Tetanus-Acellular Pertussis"],"enrollment":18,"completionDate":"2018-10-22"},{"nctId":"NCT00508261","phase":"PHASE3","title":"Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-08-01","conditions":["Infections, Meningococcal"],"enrollment":793,"completionDate":"2008-10-27"},{"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,"completionDate":"2009-02-17"},{"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,"completionDate":"2007-11-15"},{"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,"completionDate":"2008-08-28"},{"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,"completionDate":"2008-05-02"},{"nctId":"NCT00988884","phase":"PHASE3","title":"A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-10-21","conditions":["Human Papillomavirus Infection"],"enrollment":1241,"completionDate":"2011-02-22"},{"nctId":"NCT02062385","phase":"PHASE3","title":"Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-05-30","conditions":["Rotavirus Gastroenteritis"],"enrollment":4040,"completionDate":"2015-06-11"},{"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,"completionDate":"2013-05-09"},{"nctId":"NCT00290342","phase":"PHASE3","title":"Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-01-01","conditions":["Tetanus","Acellular Pertussis","Diphtheria"],"enrollment":458,"completionDate":"2007-01-23"},{"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,"completionDate":"2018-06-27"},{"nctId":"NCT01153893","phase":"PHASE3","title":"Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-10-04","conditions":["Infections, Streptococcal"],"enrollment":105,"completionDate":"2011-02-16"},{"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,"completionDate":"2011-02-17"},{"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,"completionDate":"2008-12-30"},{"nctId":"NCT01090453","phase":"PHASE2","title":"Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05-17","conditions":["Tetanus","Hepatitis B","Haemophilus Influenzae Type b","Poliomyelitis","Acellular Pertussis","Diphtheria","Neisseria Meningitidis"],"enrollment":480,"completionDate":"2011-10-11"},{"nctId":"NCT01147900","phase":"PHASE4","title":"Evaluation of Boostrix™10 Years After Previous Booster Vaccination","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-15","conditions":["Acellular Pertussis","Tetanus","Diphtheria"],"enrollment":180,"completionDate":"2012-05-08"},{"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,"completionDate":"2010-11-26"},{"nctId":"NCT00197236","phase":"PHASE3","title":"Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-11-11","conditions":["Hepatitis A"],"enrollment":468,"completionDate":"2007-12-03"},{"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","Haemophilus Influenzae Type b","Acellular Pertussis","Diphtheria"],"enrollment":721,"completionDate":"2012-01-05"},{"nctId":"NCT01245049","phase":"PHASE3","title":"Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-04-01","conditions":["Acellular Pertussis","Poliomyelitis","Tetanus","Diphtheria"],"enrollment":387,"completionDate":"2012-04-02"},{"nctId":"NCT00282295","phase":"PHASE4","title":"US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-01-25","conditions":["Acellular Pertussis","Tetanus","Diphtheria"],"enrollment":1344,"completionDate":"2006-08-08"},{"nctId":"NCT01362322","phase":"PHASE4","title":"Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-07-01","conditions":["Diphtheria","Tetanus","Acellular Pertussis"],"enrollment":671,"completionDate":"2012-09-03"},{"nctId":"NCT00346073","phase":"PHASE3","title":"Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-07-13","conditions":["Acellular Pertussis","Diphtheria","Tetanus"],"enrollment":2337,"completionDate":"2007-03-07"},{"nctId":"NCT01171963","phase":"PHASE3","title":"Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-08-29","conditions":["Infections, Rotavirus"],"enrollment":3340,"completionDate":"2012-05-12"},{"nctId":"NCT01988857","phase":"PHASE3","title":"Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-02-22","conditions":["Diphtheria","Tetanus","Acellular Pertussis"],"enrollment":302,"completionDate":"2014-05-10"},{"nctId":"NCT00369824","phase":"PHASE3","title":"Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-09-26","conditions":["Infections, Papillomavirus"],"enrollment":1330,"completionDate":"2008-02-13"},{"nctId":"NCT00426361","phase":"PHASE3","title":"Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-02-13","conditions":["Infections, Papillomavirus"],"enrollment":751,"completionDate":"2008-07-25"},{"nctId":"NCT00258882","phase":"","title":"Descriptive, Post-marketing, Passive Surveillance Safety Study of ADACEL™ Vaccine","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2006-01","conditions":["Pertussis"],"enrollment":327293,"completionDate":"2012-12"},{"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,"completionDate":"2013-07-17"},{"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,"completionDate":"2006-03-03"},{"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,"completionDate":"2008-06-06"},{"nctId":"NCT00871741","phase":"PHASE2","title":"Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2009-04-01","conditions":["Tetanus","Poliomyelitis","Neisseria Meningitidis","Haemophilus Influenzae Type b","Diphtheria","Acellular Pertussis","Hepatitis B"],"enrollment":16,"completionDate":"2009-06-25"},{"nctId":"NCT00871000","phase":"PHASE3","title":"Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-04-01","conditions":["Acellular Pertussis","Tetanus","Diphtheria","Poliomyelitis"],"enrollment":303,"completionDate":"2009-11-18"},{"nctId":"NCT00412854","phase":"PHASE3","title":"Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-01-03","conditions":["Tetanus","Diphtheria","Acellular Pertussis"],"enrollment":660,"completionDate":"2007-06-25"},{"nctId":"NCT01323959","phase":"PHASE4","title":"Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-04-01","conditions":["Acellular Pertussis","Poliomyelitis","Diphtheria","Tetanus"],"enrollment":212,"completionDate":"2012-03-01"},{"nctId":"NCT01738477","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-01-31","conditions":["Tetanus","Acellular Pertussis","Diphtheria"],"enrollment":165,"completionDate":"2014-04-02"},{"nctId":"NCT02052661","phase":"PHASE4","title":"This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-02-18","conditions":["Hepatitis B"],"enrollment":301,"completionDate":"2014-09-23"},{"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","Haemophilus Influenzae Type b"],"enrollment":831,"completionDate":"2012-01-16"},{"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","Haemophilus Influenzae Type b","Tetanus","Hepatitis B"],"enrollment":403,"completionDate":"2008-08-18"},{"nctId":"NCT00696423","phase":"PHASE3","title":"Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-06-07","conditions":["Acellular Pertussis","Diphtheria","Tetanus"],"enrollment":467,"completionDate":"2008-07-26"},{"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","Poliomyelitis","Acellular Pertussis"],"enrollment":702,"completionDate":"2007-02-01"},{"nctId":"NCT01333813","phase":"PHASE4","title":"Hepatitis B Antibody Persistence and Immune Response to Hepatitis B Vaccine Challenge in Previously Vaccinated Children","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-04-26","conditions":["Hepatitis B"],"enrollment":300,"completionDate":"2011-09-28"},{"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","Diphtheria","Haemophilus Influenzae Type b"],"enrollment":985,"completionDate":"2010-11-19"},{"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","Diphtheria","Hepatitis B"],"enrollment":283,"completionDate":"2008-06-25"},{"nctId":"NCT00635128","phase":"PHASE4","title":"Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-02-01","conditions":["Poliomyelitis","Diphtheria","Tetanus","Acellular Pertussis"],"enrollment":415,"completionDate":"2008-07-08"},{"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","Tetanus","Poliomyelitis"],"enrollment":50,"completionDate":"2010-04-12"},{"nctId":"NCT00610168","phase":"PHASE4","title":"Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2008-01-01","conditions":["Acellular Pertussis","Tetanus","Diphtheria"],"enrollment":82,"completionDate":"2008-04-30"},{"nctId":"NCT00432042","phase":"PHASE3","title":"Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2007-01-12","conditions":["Varicella","Measles","Mumps","Rubella","Diphtheria","Tetanus","Pertussis","Poliomyelitis","Hepatitis B","Haemophilus Infections"],"enrollment":955,"completionDate":"2008-03-27"},{"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","Tetanus","Poliomyelitis"],"enrollment":0,"completionDate":"2018-08-01"},{"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)","Poliomyelitis","Pertussis","Tetanus"],"enrollment":312,"completionDate":"1999-09"},{"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)","Poliomyelitis","Pertussis","Tetanus"],"enrollment":440,"completionDate":"2000-03"},{"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,"completionDate":"2010-06"},{"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,"completionDate":"2006-12"},{"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,"completionDate":"2010-09"},{"nctId":"NCT00327184","phase":"PHASE3","title":"Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2006-04","conditions":["Neisseria Meningitidis","Haemophilus Influenzae Type b"],"enrollment":709,"completionDate":"2006-11"},{"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,"completionDate":"2006-10"},{"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,"completionDate":"2006-07"},{"nctId":"NCT01294605","phase":"PHASE4","title":"Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2003-04","conditions":["Acellular Pertussis","Tetanus","Diphtheria"],"enrollment":460,"completionDate":"2004-09"},{"nctId":"NCT01277705","phase":"PHASE3","title":"Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2002-01","conditions":["Tetanus","Diphtheria","Acellular Pertussis"],"enrollment":806,"completionDate":"2002-04"},{"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","Diphtheria","Tetanus","Poliomyelitis"],"enrollment":80,"completionDate":"2001-04"},{"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","Acellular Pertussis","Tetanus","Haemophilus Influenzae Type b"],"enrollment":494,"completionDate":"2005-05"},{"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","Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type B Infection"],"enrollment":881,"completionDate":"2009-07"},{"nctId":"NCT00258908","phase":"PHASE3","title":"Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan","status":"COMPLETED","sponsor":"Sanofi Pasteur, a Sanofi Company","startDate":"2005-11","conditions":["Diphtheria","Tetanus","Pertussis"],"enrollment":115,"completionDate":"2006-08"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Merck Sharp & Dohme LLC","relationship":"Original Developer"}],"publicationCount":5,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"originalDeveloper":"Merck Sharp & Dohme LLC","recentPublications":[{"date":"2026","pmid":"41704959","title":"Diphtheria-tetanus-acellular pertussis vaccine safety in children under 7 years: a post-marketing analysis of the U.S. vaccine adverse event reporting system.","journal":"Frontiers in cellular and infection microbiology"},{"date":"2016 Apr","pmid":"27069343","title":"Quadracel: Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis in Children.","journal":"P & T : a peer-reviewed journal for formulary management"},{"date":"2015 Sep 4","pmid":"26334944","title":"Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine and Guidance for Use as a Booster Dose.","journal":"MMWR. Morbidity and mortality weekly report"},{"date":"2009 Jan","pmid":"19117896","title":"Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial.","journal":"Pediatrics"},{"date":"2002 Jul 5","pmid":"12139185","title":"Food and Drug Administration approval of a fifth acellular pertussis vaccine for use among infants and young children--United States, 2002.","journal":"MMWR. Morbidity and mortality weekly report"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","brandName":"DAPTACEL™","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Biologic","firstApprovalDate":"","aiSummary":"","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":1,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:12:59.100638+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":false,"safety":true,"trials":true,"score":2}}