[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588906":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":37,"id":67,"slug":37,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":37,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":37,"studyType":80,"phases":81,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"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,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Care CT Group","RECRUITING","Dasmariñas","Cavite","Philippines",{"type":55,"coordinates":56},"Point",[57,58],120.93667,14.32944,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":63,"phoneExt":37,"email":64},"Principal Investigator","639 178526026","dcyumd@gmail.com",{"type":66,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","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":78,"type":79},1186,"ESTIMATED","INTERVENTIONAL",[82,83],"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",[86,87,88,89,90,91],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type b",[93],"vaccination","2025-06-30",{"date":96,"type":97},"2025-07-03","ACTUAL",{"date":99,"type":97},"2025-05-30",{"date":101,"type":79},"2027-04",{"name":5,"class":6},1]