[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588906":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":66,"collaborators":37,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":37,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":37,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"LG Chem","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group 1 for Stage 1","EXPERIMENTAL","LBVD",[13],"Biological: LBVD",{"label":15,"type":10,"description":16,"interventionNames":17},"Test group 1 for Stage 2","LBVD Lot A",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Test group 2 for Stage 2","LBVD Lot B",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Test group 3 for Stage 2","LBVD Lot C",[13],{"label":27,"type":28,"description":29,"interventionNames":30},"Control group for Stage 1 and Stage 2","ACTIVE_COMPARATOR","Co-administration of Pentavalent vaccine and Inactivated Polio vaccine",[31],"Biological: Pentavalent vaccine and Inactivated Polio vaccine",[33,38],{"type":34,"name":11,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","Intramuscular injection into the anterolateral area of the thigh",[9,15,19,23],null,{"type":34,"name":39,"description":35,"armGroupLabels":40,"otherNames":37},"Pentavalent vaccine and Inactivated Polio vaccine",[27],[42],{"name":43,"role":44,"phone":45,"phoneExt":37,"email":46},"Clinical Study Lead","CONTACT","+82-2-6987-4156","lgclinical@lgchem.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":37,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Care CT Group","RECRUITING","Dasmariñas","Cavite","Philippines","PH",{"type":56,"coordinates":57},"Point",[58,59],120.93667,14.32944,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":37,"email":65},"Principal Investigator","639 178526026","dcyumd@gmail.com",{"type":67,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100588906","phase-2-a-phase-iiiii-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-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":80,"type":81},1186,"ESTIMATED","INTERVENTIONAL",[84,85],"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",[88,89,90,91,92,93],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type b",[95],"vaccination","2025-06-30",{"date":98,"type":99},"2025-07-03","ACTUAL",{"date":101,"type":99},"2025-05-30",{"date":103,"type":81},"2027-04",{"name":5,"class":6},1]