[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562637":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":25,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":25,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Jiangsu Province Centers for Disease Control and Prevention","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Intervention group: 1 dose of DTaP-IPV\u002FHib Pentavalent Vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age.",[13],"Procedure: Different immunization regiments with DTaP-IPV\u002FHib Pentavalent Vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Control group: 1 dose of DTaP-IPV\u002FHib Pentavalent Vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Different immunization regiments with DTaP-IPV\u002FHib Pentavalent Vaccine","The test vaccine in this study was Pentaxim®, a pentavalent vaccine produced by Sanofi Pasteur, France.This vaccine is a combination vaccine consisting of adsorbed acellular DTP and inactivated polio vaccine (DTaP-IPV) and Haemophilus influenzae type b conjugate vaccine (Hib).\n\n1. Intervention group: 1 dose of experimental vaccine at 2, 4 and 6 months of age, and 1 dose of enhanced vaccine at 18 months of age.\n2. Control group: 1 dose of experimental vaccine at 2, 3 and 4 months of age, and 1 dose of enhanced vaccine at 18 months of age.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"jingxin42102209@126.com Li","Jingsu Provincial Centre of Disease Control and Prevention","STUDY_DIRECTOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Jingxin Li","CONTACT","+8613813865838","jingxin42102209@126.com",[38],{"facility":29,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Nanjing","Jiangsu","210009","China","CN",{"type":46,"coordinates":47},"Point",[48,49],118.77778,32.06167,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},{"type":54,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100562637","safety-and-immunogenicity-of-dtap-ipvhib-pentavalent-vaccine-in-chinese-2-month-old-infants-100562637",false,"NCT06605755","Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants","Extended Study on the Safety and Immunogenicity of DTaP-IPV\u002FHib Pentavalent Vaccine in Chinese 2-month-old Infants: a Randomized, Prospective, Open Clinical Study","Inclusion Criteria:\n\n\\- (1)Received 4 doses of DTaP-IPV\u002FHib pentavalent vaccines (2) Obtained consent from the participant's caregiver and sign an informed consent form\n\nExclusion Criteria:\n\n-(1) Diagnosed by a physician with a coagulation abnormality (e.g., coagulation factor deficiency, coagulopathy, platelet abnormality) (2) Any other factor considered to make participation in the trial unsuitable.",true,"ALL","19 Months","22 Months",{"count":67,"type":68},785,"ESTIMATED","INTERVENTIONAL",[71],"NA","The main purpose of this study is to evaluate immune persistence at 30 and 36 Months of Age and Pertussis Breakthrough Infections between 19 and 36 Months of Age following two regiments of DTaP-IPV\u002FHib Pentavalent Vaccine in Healthy 2-Month-Old Infants and Children in China.",[74,75,76,77,78],"Pertussis","Diphtheria","Tetanus","Haemophilus Influenzae Type B Infection","Polio","2024-09-18",{"date":81,"type":82},"2024-09-20","ACTUAL",{"date":84,"type":82},"2024-09-05",{"date":86,"type":68},"2026-02",{"name":5,"class":6},1]