[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563594":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":34,"responsibleParty":44,"collaborators":34,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":34,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":34,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":34,"overallStatus":71,"whyStopped":34,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":34},{"fullName":5,"class":6},"LG Chem","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Test group 1","EXPERIMENTAL","Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)",[13],"Biological: LR20062",{"label":15,"type":10,"description":16,"interventionNames":17},"Test group 2","Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Test group 3","High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Test group 4","ACTIVE_COMPARATOR","Control hexavalent vaccine (DTaP-HepB-IPV-Hib)",[27],"Biological: DTaP-HepB-IPV-Hib vaccine",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"BIOLOGICAL","LR20062","DTaP-HepB-IPV-Hib vaccine",[9,15,19],null,{"type":30,"name":32,"description":36,"armGroupLabels":37,"otherNames":34},"Control hexavalent vaccine",[23],[39],{"name":40,"role":41,"phone":42,"phoneExt":34,"email":43},"Clinical Study Lead","CONTACT","82-2-6987-4427","lgclinical@lgchem.com",{"type":45,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100563594","phase-2-study-to-evaluate-the-immunogenicity-of-lr20062-compared-to-control-when-administered-intramuscularly-in-healthy-infants-at-2-4-6-months-of-age-100563594",false,"NCT06618196","Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age","A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age","Inclusion Criteria:\n\n1. Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.\n2. Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.\n\nExclusion Criteria:\n\nMedical conditions:\n\n1. Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.\n2. Has a known SARS-CoV-2 infection at Screening.\n3. Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.\n4. Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.\n5. Had a recent febrile illness, defined as axillary temperature ≥38.0℃ \\[≥100.4℉\\] occurring at or within 72 hours prior to receipt of study vaccine.\n\n   Prior\u002Fconcomitant therapy:\n6. Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and\u002For Hib infections since birth.\n7. Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.\n8. Meets one or more of the following systemic corticosteroid exclusion criteria:\n\n   1. Has received systemic corticosteroids (equivalent of ≥0.5 mg\u002Fkg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.\n   2. Is expected to require any systemic corticosteroids during conduct of the study.\n\n   Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.\n9. Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.\n\nException: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.",true,"ALL","50 Days","70 Days",{"count":58,"type":59},336,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.",[65,66,67,68,69,70],"Diphtheria","Tetanus","Pertussis","Hepatitis B","Poliomyelitis","Haemophilus Influenzae Type B Infection","NOT_YET_RECRUITING","2024-09-26",{"date":74,"type":75},"2024-10-01","ACTUAL",{"date":77,"type":59},"2024-10-02",{"date":79,"type":59},"2026-04-30",{"name":5,"class":6}]