[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"haemophilus-influenzae-type-b\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:haemophilus-influenzae-type-b":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100588906",false,"NCT06947499","A Phase II\u002FIII Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series","A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II\u002FIII Clinical Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series","Inclusion Criteria:\n\n* healthy infants from 6 weeks to 8 weeks of age (both inclusive)\n* body weight ≥ 3.2 kg\n* born at full term pregnancy (≥ 37 weeks)\n* signed informed consent by parent(s) or legally acceptable representative(s)\n\nExclusion Criteria:\n\n* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis\n* Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration\n* Known history of SARS-CoV-2 infection\n* Participant's mother is HepB antigen or HIV positive\n* Fever ≥ 38.0 C\u002F100.4 F within 3 days prior to enrollment\n* Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG)\n* Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination\n* Received immunosuppressive agents or other immune-modifying drugs\n* Previous use of blood or blood-derived products\n* Any history of allergy (hypersensitivity) to any of the vaccine components\n* Participation in another interventional clinical trial within 4 weeks of expected first vaccination",true,"ALL","6 Weeks","8 Weeks",{"count":20,"type":21},1186,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants",[28,29,30,31,32,33],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type b",[35],"vaccination","RECRUITING","2025-06-30",{"date":39,"type":40},"2025-07-03","ACTUAL",{"date":42,"type":40},"2025-05-30",{"date":44,"type":21},"2027-04",{"name":46,"class":47},"LG Chem","INDUSTRY",""]