[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586798":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":53,"locations":60,"responsibleParty":171,"collaborators":35,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":35,"eligibilityCriteria":179,"healthyVolunteers":180,"sex":181,"minAge":182,"maxAge":182,"enrollmentInfo":183,"targetDuration":35,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":35,"overallStatus":193,"whyStopped":35,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Institute of Medical Biology, Chinese Academy of Medical Sciences","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"sIPV + DTaP (concomitant vaccination cohort)","EXPERIMENTAL","sIPV at 2,3,4 and 18 months of age, DTaP at 2,4,6 and 18 months of age",[13,14],"Biological: sIPV","Biological: DTaP",{"label":16,"type":10,"description":17,"interventionNames":18},"sIPV\u002FbOPV + DTaP (concomitant vaccination cohort)","sIPV at 2,3 months of age and bOPV at 4 months and 4 years of age DTaP at 2, 4, 6 and 18 months of age",[13,14,19],"Biological: bOPV 1,3",{"label":21,"type":10,"description":22,"interventionNames":23},"sIPV + DTaP + MMR (systematic interval-based vaccination cohort)","sIPV at 2,3,4 and 18 months of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV MMR at 18 months of age, randomly assigned in the concomitant administration with sIPV or 1 month after the administration of DTaP",[13,14,24],"Biological: MMR Vaccine",{"label":26,"type":10,"description":27,"interventionNames":28},"sIPV\u002FbOPV + DTaP (Systematic interval-based vaccination cohort)","sIPV at 2,3 months of age, bOPV at 4 months and 4 years of age DTaP at 2,4,6 and 18 months of age, 7 days after the administration of sIPV",[13,14,19],[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","sIPV","Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose",[9,21,26,16],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"DTaP","Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose",[9,21,26,16],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"bOPV 1,3","Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose",[26,16],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"MMR Vaccine","Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose",[21],[49],{"name":50,"affiliation":51,"role":52},"Yan Zheng","Yunnan Provical Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Jingsi Yang","CONTACT","0871-68334551","+86","yjs@imbcams.com.cn",[61,79,90,101,112,121,135,146,157],{"facility":62,"status":35,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Lufeng Center for Disease Control and Prevenion","Chuxiong","Yunnan","651299","China","CN",{"type":69,"coordinates":70},"Point",[71,72],101.54556,25.03639,{"lat":72,"lon":71},[75],{"name":76,"role":56,"phone":77,"phoneExt":58,"email":78},"Jian Li","0878-4125708","lfcdcmy@126.com",{"facility":80,"status":35,"city":63,"state":64,"zip":81,"country":66,"countryCode":67,"cosmosGeoPoint":82,"geoPoint":84,"contacts":85},"Yuanmou Center for Disease Control and Prevention","651300",{"type":69,"coordinates":83},[71,72],{"lat":72,"lon":71},[86],{"name":87,"role":56,"phone":88,"phoneExt":58,"email":89},"Wanqun 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Tan","0876-4122173","343311329@qq.com",{"facility":147,"status":35,"city":123,"state":64,"zip":148,"country":66,"countryCode":67,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"Guangnan Center for Disease Control and Prevention","663300",{"type":69,"coordinates":150},[127,128],{"lat":128,"lon":127},[153],{"name":154,"role":56,"phone":155,"phoneExt":58,"email":156},"Tingzhao Lin","13688726934","535224629@qq.com",{"facility":158,"status":35,"city":159,"state":64,"zip":160,"country":66,"countryCode":67,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Mile Center for Disease Control and Prevention","Yisa","652399",{"type":69,"coordinates":162},[163,164],102.44711,23.33231,{"lat":164,"lon":163},[167],{"name":168,"role":56,"phone":169,"phoneExt":58,"email":170},"Pinjing Chen","18988262848","2075499584@qq.com",{"type":172,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100586798","phase-4-study-of-concomitant-administration-of-the-sipv-and-dtap-or-mmr-100586798",false,"NCT06920069","Study of Concomitant Administration of the sIPV and DTaP or MMR","Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Adsorbed Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine or Measles, Mumps and Rubella Combined Live-attenuated Vaccine","Inclusion Criteria:\n\n* Age Requirement: Infants aged 2 months at the time of enrollment\n* Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.\n* Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, and sign the informed consent form.\n* Adherence: Legal guardians or appointed representatives of volunteers must be able to comply with the requirements in the study as well as complete relevant visits on time.\n* Birth Condition: Full-term at birth (gestational age ≥ 37 weeks and \\\u003C 42 weeks) and birth weight ≥ 2500g\n\nExclusion Criteria:\n\n* Vaccination History: received vaccines containing diphtheria-tetanus-pertussis antigens, polio antigens, Hib conjugate vaccine, or 13-valent pneumococcal conjugate vaccine before enrollment.\n* Those who had received blood transfusions or used blood products (except hepatitis B immunoglobulin) before enrollment.\n* Recent Vaccination: Volunteers received any inactivated vaccines or subunit vaccines within 7 days (including the 7th day) prior to vaccination with the investigational vaccine, or any other live attenuated vaccines within 14 days (including the 14th day) prior to vaccination.\n* Acute Illness: Volunteers have experienced acute illnesses (e.g., fever) within 3 days before enrollment, or have used antipyretic analgesics or antihistamines within 3 days.\n* Allergic History: Volunteers who are allergic to any component of sIPV, bOPV, DTaP, or MMR, or who are allergic to kanamycin sulfate, kanamycin, or gentamicin sulfate, or those with an allergic constitution.\n* Birth Condition: Severe neonatal diseases caused by abnormal delivery and other reasons, such as birth trauma, neonatal asphyxia, respiratory distress syndrome, neonatal intracranial hemorrhage, etc., or patients with clinically confirmed severe hyperbilirubinemia.\n* Neurological and Mental Health: Volunteers with encephalopathy, convulsions, epilepsy, or other progressive neurological disorders, or those whose families have a history of genetic predisposition to convulsions or epilepsy, or a history of genetic predisposition to mental illness.\n* History of Related Illness: Volunteers who have a history of poliomyelitis, pertussis, diphtheria, tetanus, measles, rubella, or mumps.\n* Immune Therapy: Volunteers with immunodeficiency, weakened immune function, or those who have received immunosuppressive therapy (such as long-term systemic glucocorticoid treatment, but excluding local medications like inhalants or nasal sprays).\n* Other Diseases: Volunteers with severe diseases, encompassing those in the cardiovascular system, blood and lymphatic systems, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolism, and bones, etc.\n* Participation in Other Clinical Studies: Volunteers are currently or have plans to participate in other clinical studies before enrollment.\n* Investigator's Discretion: The final exclusion criterion is the investigator's discretion to determine whether a volunteer is suitable for participation in the study.",true,"ALL","2 Months",{"count":184,"type":185},2640,"ESTIMATED","INTERVENTIONAL",[188],"PHASE4","This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer\u002Fconcentration (GMT\u002FGMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.",[191,192,45],"Polio","Diphteria, Tetanus and Pertussis","NOT_YET_RECRUITING","2025-04-14",{"date":196,"type":197},"2025-04-17","ACTUAL",{"date":199,"type":185},"2025-05-15",{"date":201,"type":185},"2031-06-15",{"name":5,"class":6},9]