[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653919":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":56,"studyPopulation":45,"armGroups":57,"interventions":74,"overallOfficials":88,"centralContacts":92,"locations":98,"responsibleParty":351,"collaborators":353,"id":357,"slug":358,"hasResults":359,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":45,"eligibilityCriteria":363,"healthyVolunteers":364,"sex":365,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":45,"studyType":371,"phases":372,"briefSummary":374,"conditions":375,"keywords":382,"overallStatus":386,"whyStopped":45,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":396},{"fullName":5,"class":6},"Tanabe Pharma Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":45},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Antibody seroprotection rates against vaccine antigens in the BK1803 of Main Cohort","The antibody seroprotection rates against hepatitis B surface (HBs) antigen, polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \\[PT\\] and filamentous hemagglutinin \\[FHA\\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated.","4 weeks from the post-primary immunization of BK1803 in Main Cohort (Visit4)",{"measure":14,"description":15,"timeFrame":16},"Antibody seroprotection rates against vaccine antigens for HBs antigen in the Control of Main Cohort","The antibody seroprotection rates against hepatitis B surface (HBs) antigen will be evaluated.","4 weeks from the post-booster immunization of Bimmugen in Main Cohort (Visit6)",{"measure":18,"description":19,"timeFrame":20},"The antibody seroprotection rates against vaccine antigens for PRP, PT and FHA, diphtheria toxin, tetanus toxin, and attenuated poliovirus in the Control of Main Cohort","The antibody seroprotection rates against polyribosylribitol phosphate (PRP), Bordetella pertussis (pertussis toxin \\[PT\\] and filamentous hemagglutinin \\[FHA\\]), diphtheria toxin, tetanus toxin, and attenuated poliovirus will be evaluated.","4 weeks from the post-primary immunization of GOBIK in Main Cohort (Visit4)",[22,26,30,33,36,39,42],{"measure":23,"description":24,"timeFrame":25},"Geometric mean antibody titers for HBs antigen","Geometric mean antibody titers against hepatitis B surface (HBs) antigen will be evaluated.","4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization of BK1803 and the post-booster immunization of BK1803\u002FBimmugen in Main Cohort (Visit 4,6,8)",{"measure":27,"description":28,"timeFrame":29},"Geometric mean antibody titers for PRP","Geometric mean antibody titers against PRP will be evaluated.","4 weeks from the post-primary immunization and the post-booster immunization in Safety Lead-in Cohort (Visit 4 and 8); 4 weeks from the post-primary immunization and the post-booster immunization of BK1803\u002FGOBIK in Main Cohort (Visit 4 and 8)",{"measure":31,"description":32,"timeFrame":29},"Geometric mean antibody titers for Bordetella pertussis (PT and FHA)","Geometric mean antibody titers against Bordetella pertussis (PT and FHA) will be evaluated.",{"measure":34,"description":35,"timeFrame":29},"Geometric mean antibody titers for diphtheria toxin","Geometric mean antibody titers against diphtheria toxin will be evaluated.",{"measure":37,"description":38,"timeFrame":29},"Geometric mean antibody titers for tetanus toxin","Geometric mean antibody titers against tetanus toxin will be evaluated.",{"measure":40,"description":41,"timeFrame":29},"Geometric mean antibody titers for attenuated poliovirus","Geometric mean antibody titers against attenuated poliovirus will be evaluated.",{"measure":43,"description":11,"timeFrame":44},"Antibody seroprotection rates against vaccine antigens","4 weeks from the post-primary and the post-booster of BK1803 in Safety Lead-in Cohort (visit 4and 8); 4 weeks from the post-booster of BK1803\u002FGOBIK in Main Cohort (visit 8)",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":45,"timePerspective":45,"maskingInfo":51},"RANDOMIZED","PARALLEL","Participants are randomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection.","PREVENTION",{"masking":52,"maskingDescription":53,"whoMasked":54},"SINGLE","This is an observer-blinded study in which outcome assessors are blinded to treatment assignment. Due to differences in administration methods and study procedures, participants and care providers are not blinded. Measures are taken to maintain blinding of outcome assessors, including separation of personnel involved in vaccination and those involved in outcome evaluation.",[55],"OUTCOMES_ASSESSOR","This is a phase 3, randomized, observer-blinded, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants.\n\nBK1803 is a combined vaccine containing antigens against diphtheria, pertussis, tetanus, inactivated poliovirus, Haemophilus influenzae type b (Hib), and hepatitis B. This study aims to assess whether BK1803 provides immunogenicity comparable to standard vaccination regimens.\n\nThe study consists of two cohorts: a safety lead-in cohort and a main cohort. In the safety lead-in cohort, participants receive BK1803 to evaluate its initial safety and tolerability before initiating the main cohort. In the main cohort, participants are randomized in a 1:1 ratio to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection.\n\nParticipants will receive primary and booster immunizations according to the study schedule, and immunogenicity will be evaluated based on antibody responses to multiple vaccine antigens. Safety will be monitored throughout the study period.",[58,64,67],{"label":59,"type":60,"description":61,"interventionNames":62},"Safety Lead-in Cohort: BK1803","EXPERIMENTAL","Subjects receive BK1803 administered according to the study vaccination schedule, including primary and booster immunizations.",[63],"Biological: BK1803",{"label":65,"type":60,"description":61,"interventionNames":66},"Main Cohort: BK1803",[63],{"label":68,"type":69,"description":70,"interventionNames":71},"Main Cohort: Control (GOBIK and Bimmugen)","ACTIVE_COMPARATOR","Subjects receive control vaccines consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection according to the study vaccination schedule, including primary and booster immunizations.",[72,73],"Biological: GOBIK Aqueous Suspension Syringes","Biological: Bimmugen® Injection",[75,80,84],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":45},"BIOLOGICAL","BK1803","BK1803 is a combination vaccine administered intramuscularly according to the study vaccination schedule, including primary and booster immunizations.",[65,59],{"type":76,"name":81,"description":82,"armGroupLabels":83,"otherNames":45},"GOBIK Aqueous Suspension Syringes","GOBIK Aqueous Suspension Syringes is a combination vaccine administered intramuscularly according to the study vaccination schedule.",[68],{"type":76,"name":85,"description":86,"armGroupLabels":87,"otherNames":45},"Bimmugen® Injection","Bimmugen® Injection is a hepatitis B vaccine administered subcutaneously according to the study vaccination schedule.",[68],[89],{"name":90,"affiliation":5,"role":91},"General Manager","STUDY_DIRECTOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":45,"email":97},"Clinical Trials Information Desk","CONTACT","Please email","cti-inq-ml.JP@ml.tanabe-pharma.com",[99,112,121,127,133,139,145,155,164,173,179,184,193,199,205,215,225,229,238,247,256,261,270,278,287,296,305,310,319,329,334,338,347],{"facility":100,"status":45,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":45},"Fukui Aiiku Hospital","Fukui-shi","Fukui","910-0833","Japan","JP",{"type":107,"coordinates":108},"Point",[109,110],136.22257,36.06443,{"lat":110,"lon":109},{"facility":113,"status":45,"city":114,"state":114,"zip":115,"country":104,"countryCode":105,"cosmosGeoPoint":116,"geoPoint":120,"contacts":45},"Oda Children's Allergy Clinic","Fukuoka","810-0022",{"type":107,"coordinates":117},[118,119],130.41667,33.6,{"lat":119,"lon":118},{"facility":122,"status":45,"city":114,"state":114,"zip":123,"country":104,"countryCode":105,"cosmosGeoPoint":124,"geoPoint":126,"contacts":45},"Morooka Chirdren's Chikushi-dori Clinic","812-0894",{"type":107,"coordinates":125},[118,119],{"lat":119,"lon":118},{"facility":128,"status":45,"city":114,"state":114,"zip":129,"country":104,"countryCode":105,"cosmosGeoPoint":130,"geoPoint":132,"contacts":45},"Shindo children's clinic","814-0121",{"type":107,"coordinates":131},[118,119],{"lat":119,"lon":118},{"facility":134,"status":45,"city":114,"state":114,"zip":135,"country":104,"countryCode":105,"cosmosGeoPoint":136,"geoPoint":138,"contacts":45},"Kurokawa Michiko Pediatric Clinic","815-0033",{"type":107,"coordinates":137},[118,119],{"lat":119,"lon":118},{"facility":140,"status":45,"city":114,"state":114,"zip":141,"country":104,"countryCode":105,"cosmosGeoPoint":142,"geoPoint":144,"contacts":45},"Japanese Red Cross Fukuoka Hospital","815-8555",{"type":107,"coordinates":143},[118,119],{"lat":119,"lon":118},{"facility":146,"status":45,"city":147,"state":148,"zip":149,"country":104,"countryCode":105,"cosmosGeoPoint":150,"geoPoint":154,"contacts":45},"Isesaki Municipal Hospital","Isesaki","Gunma","372-0817",{"type":107,"coordinates":151},[152,153],139.2,36.31667,{"lat":153,"lon":152},{"facility":156,"status":45,"city":157,"state":148,"zip":158,"country":104,"countryCode":105,"cosmosGeoPoint":159,"geoPoint":163,"contacts":45},"Japanese Red Cross Maebashi Hospital","Maebashi","371-0811",{"type":107,"coordinates":160},[161,162],139.08333,36.4,{"lat":162,"lon":161},{"facility":165,"status":45,"city":166,"state":166,"zip":167,"country":104,"countryCode":105,"cosmosGeoPoint":168,"geoPoint":172,"contacts":45},"Yoshimitsu Pediatric Clinic","Hiroshima","731-0124",{"type":107,"coordinates":169},[170,171],132.45,34.4,{"lat":171,"lon":170},{"facility":174,"status":45,"city":166,"state":166,"zip":175,"country":104,"countryCode":105,"cosmosGeoPoint":176,"geoPoint":178,"contacts":45},"Taniguchi Children Clinic","732-0023",{"type":107,"coordinates":177},[170,171],{"lat":171,"lon":170},{"facility":180,"status":45,"city":181,"state":182,"zip":183,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Ishikari Kids Clinic","Ishikari-shi","Hokkaido","061-3202",{"facility":185,"status":45,"city":186,"state":182,"zip":187,"country":104,"countryCode":105,"cosmosGeoPoint":188,"geoPoint":192,"contacts":45},"Hibarigaoka Kodomo Clinic","Sapporo","004-0052",{"type":107,"coordinates":189},[190,191],141.35,43.06667,{"lat":191,"lon":190},{"facility":194,"status":45,"city":186,"state":182,"zip":195,"country":104,"countryCode":105,"cosmosGeoPoint":196,"geoPoint":198,"contacts":45},"Araki Children Clinic","006-0814",{"type":107,"coordinates":197},[190,191],{"lat":191,"lon":190},{"facility":200,"status":45,"city":186,"state":182,"zip":201,"country":104,"countryCode":105,"cosmosGeoPoint":202,"geoPoint":204,"contacts":45},"Japan Community Healthcare Organization Hokkaido Hospital","062-8618",{"type":107,"coordinates":203},[190,191],{"lat":191,"lon":190},{"facility":206,"status":45,"city":207,"state":208,"zip":209,"country":104,"countryCode":105,"cosmosGeoPoint":210,"geoPoint":214,"contacts":45},"Kumagai Children's Clinic","Amagasaki","Hyōgo","661-0953",{"type":107,"coordinates":211},[212,213],135.41667,34.71667,{"lat":213,"lon":212},{"facility":216,"status":45,"city":217,"state":218,"zip":219,"country":104,"countryCode":105,"cosmosGeoPoint":220,"geoPoint":224,"contacts":45},"Hamami Kodomo Clinic","Chigasaki","Kanagawa","253-0062",{"type":107,"coordinates":221},[222,223],139.40434,35.33638,{"lat":223,"lon":222},{"facility":226,"status":45,"city":227,"state":218,"zip":228,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Kawasaki Municipal Hospital","Kawasaki-shi","210-0013",{"facility":230,"status":45,"city":231,"state":218,"zip":232,"country":104,"countryCode":105,"cosmosGeoPoint":233,"geoPoint":237,"contacts":45},"Sagamihara Kyodo Hospital","Sagamihara","252-5188",{"type":107,"coordinates":234},[235,236],139.24167,35.56707,{"lat":236,"lon":235},{"facility":239,"status":45,"city":240,"state":240,"zip":241,"country":104,"countryCode":105,"cosmosGeoPoint":242,"geoPoint":246,"contacts":45},"Kochi Health Sciences Center","Kochi","781-8555",{"type":107,"coordinates":243},[244,245],133.53333,33.55,{"lat":245,"lon":244},{"facility":248,"status":45,"city":249,"state":249,"zip":250,"country":104,"countryCode":105,"cosmosGeoPoint":251,"geoPoint":255,"contacts":45},"Sakuranbo Kodomo Clinic","Kumamoto","862-0924",{"type":107,"coordinates":252},[253,254],130.69181,32.80589,{"lat":254,"lon":253},{"facility":257,"status":45,"city":258,"state":259,"zip":260,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Ina Central Hospital","Ina-shi","Nagano","396-8555",{"facility":262,"status":45,"city":263,"state":259,"zip":264,"country":104,"countryCode":105,"cosmosGeoPoint":265,"geoPoint":269,"contacts":45},"JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital","Matsumoto","390-8510",{"type":107,"coordinates":266},[267,268],137.96667,36.23333,{"lat":268,"lon":267},{"facility":271,"status":45,"city":259,"state":259,"zip":272,"country":104,"countryCode":105,"cosmosGeoPoint":273,"geoPoint":277,"contacts":45},"Arakawa Family Clinic","381-0025",{"type":107,"coordinates":274},[275,276],138.18333,36.65,{"lat":276,"lon":275},{"facility":279,"status":45,"city":280,"state":259,"zip":281,"country":104,"countryCode":105,"cosmosGeoPoint":282,"geoPoint":286,"contacts":45},"Asama General Hospital","Saku","385-8558",{"type":107,"coordinates":283},[284,285],138.48333,36.21667,{"lat":285,"lon":284},{"facility":288,"status":45,"city":289,"state":289,"zip":290,"country":104,"countryCode":105,"cosmosGeoPoint":291,"geoPoint":295,"contacts":45},"Nara Prefecture General Medical Center","Nara","630-8581",{"type":107,"coordinates":292},[293,294],135.80485,34.68505,{"lat":294,"lon":293},{"facility":297,"status":45,"city":298,"state":298,"zip":299,"country":104,"countryCode":105,"cosmosGeoPoint":300,"geoPoint":304,"contacts":45},"Aizenbashi Hospital","Osaka","556-0005",{"type":107,"coordinates":301},[302,303],135.50107,34.69379,{"lat":303,"lon":302},{"facility":306,"status":45,"city":307,"state":308,"zip":309,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Aiwa Hospital","Kawagoe-shi","Saitama","350-0001",{"facility":311,"status":45,"city":312,"state":308,"zip":313,"country":104,"countryCode":105,"cosmosGeoPoint":314,"geoPoint":318,"contacts":45},"Hara Children's Clinic","Tokorozawa","359-1141",{"type":107,"coordinates":315},[316,317],139.46903,35.79916,{"lat":317,"lon":316},{"facility":320,"status":45,"city":321,"state":322,"zip":323,"country":104,"countryCode":105,"cosmosGeoPoint":324,"geoPoint":328,"contacts":45},"Yaizu City Hospital","Yaizu","Shizuoka","425-8505",{"type":107,"coordinates":325},[326,327],138.31952,34.86877,{"lat":327,"lon":326},{"facility":330,"status":45,"city":331,"state":332,"zip":333,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Medical Corporation Asbo Tokyo Asbo Clinic","Chuo-ku","Tokyo","104-0031",{"facility":335,"status":45,"city":336,"state":332,"zip":337,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Aquakids Clinic","Edogawa-Ku","133-0056",{"facility":339,"status":45,"city":340,"state":332,"zip":341,"country":104,"countryCode":105,"cosmosGeoPoint":342,"geoPoint":346,"contacts":45},"Okawa Children & Family Clinic","Ōta-ku","146-0095",{"type":107,"coordinates":343},[344,345],139.71605,35.56126,{"lat":345,"lon":344},{"facility":348,"status":45,"city":349,"state":332,"zip":350,"country":104,"countryCode":105,"cosmosGeoPoint":45,"geoPoint":45,"contacts":45},"Karugamo Clinic","Setagaya-Ku","156-0054",{"type":352,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[354],{"name":355,"class":356},"The Research Foundation for Microbial Diseases of Osaka University (BIKEN)","UNKNOWN","100653919","phase-3-study-of-bk1803-in-healthy-infants-100653919",false,"NCT07793513","Study of BK1803 in Healthy Infants","Confirmatory Study of BK1803 in Healthy Infants (Comparative Study Using GOBIK Aqueous Suspension Syringes and Bimmugen® Injection as a Control)","Inclusion Criteria:\n\nSubjects meeting all of the following inclusion criteria at the time of the first vaccination with the study drug will be eligible for study participation.\n\n1. Japanese healthy infants aged \\>= 2 months and \\\u003C 7 months at the time of the first vaccination with the study drug. However, although subjects meeting the following definition of \"subjects who should receive a vaccination with care\" may participate in the study, whether or not to enroll them in the study should be decided carefully by the (sub)investigator.\n2. Subjects from whose legal guardians (persons with parental rights) written consent to study participation has been obtained.\n\nSubjects Who Should Receive A Vaccination With Care 4) applies only to the Main Cohort.\n\n1. Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder\n2. Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past\n3. Subjects with a past history of convulsions\n4. (Main Cohort only) Subjects with the gestational age \\\u003C37 weeks, or who weighed less than 2500 g at birth\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria at the time of the first vaccination with the study drug will be excluded from study participation. However, (15) applies only to the Safety Lead-in Cohort.\n\n1. Subjects who have received diagnoses of immunodeficiencies in the past, or who are currently receiving treatments that cause immunosuppression\n2. Subjects with close relatives (up to third degree of kinship) who have a congenital immunodeficiency\n3. Subjects who might experience a serious allergy in response to a food, drug product (especially any component of the study drug), etc.\n4. Subjects who have had Haemophilus Influenzae type b (Hib) infections, pertussis, diphtheria, tetanus, acute poliomyelitis, or hepatitis B in the past\n5. Subjects who have received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B in the past\n6. Subjects who have received hepatitis B immunoglobulin (HBIG) for the prevention of vertical infection in the past\n7. Subjects who were born to a mother who had received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B (including a combination vaccine such as diphtheria-pertussis-tetanus vaccine) during pregnancy\n8. Subjects who are receiving anticoagulant therapy or who have thrombocytopenia or coagulation disorder\n9. Subjects with fibrodysplasia ossificans progressiva\n10. Subjects who have received live vaccines within 27 days before the first vaccination with the study drug\n11. Subjects who have received inactivated vaccines\u002Ftoxoids or mRNA vaccines within 6 days before the first vaccination with the study drug\n12. Subjects who have received blood transfusions, immunosuppressants (except for topical drugs), or immunoglobulin preparations in the past\n13. Subjects who have received corticosteroids (except for topical drugs) at a prednisolone dose level equivalent of 2 mg\u002Fkg\u002Fday or higher in the past\n14. Subjects who have participated in another clinical study and received another study drug within 12 weeks before obtaining informed consent\n15. (Safety Lead-in Cohort only) Subjects with the gestational age \\\u003C37 weeks, or who weighed less than 2500 g at birth\n16. Subjects otherwise judged to be unsuitable for participation in this study by the (sub)investigator",true,"ALL","2 Months","6 Months",{"count":369,"type":370},344,"ESTIMATED","INTERVENTIONAL",[373],"PHASE3","This study is a phase 3, randomized, observer-blinded, active-controlled, multicenter study to evaluate the immunogenicity and safety of BK1803 in healthy infants aged 2 months to less than 7 months.\n\nParticipants will be randomized to receive either BK1803 or a control regimen consisting of GOBIK Aqueous Suspension Syringes and Bimmugen® Injection. The primary objective is to demonstrate the noninferiority of BK1803 compared with the control in terms of antibody seroprotection rates against hepatitis B surface (HBs) antigen, Haemophilus influenzae type b (Hib), pertussis, diphtheria, tetanus, and poliovirus. Safety will also be assessed throughout the study.",[376,377,378,379,380,381],"Pertussis","Diphtheria","Tetanus","Poliomyelitis","Hepatitis B","Haemophilus Influenzae Type b",[380,383,376,377,378,379,384,77,385],"Haemophilus influenzae type b","Combination Vaccine","Infants","NOT_YET_RECRUITING","2026-08-26",{"date":389,"type":390},"2026-08-28","ACTUAL",{"date":392,"type":370},"2026-10",{"date":394,"type":370},"2029-04",{"name":5,"class":6},33]