[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563557":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":73,"studyPopulation":64,"armGroups":74,"interventions":87,"overallOfficials":97,"centralContacts":102,"locations":111,"responsibleParty":126,"collaborators":64,"id":128,"slug":64,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":64,"eligibilityCriteria":133,"healthyVolunteers":134,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":64,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":64,"overallStatus":113,"whyStopped":64,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":47},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg\u002Fml (seropositive rate)","Proportion of serotype-specific IgG concentration ≥0.35 μg\u002Fml","30 days after primary vaccination",{"measure":14,"description":15,"timeFrame":12},"Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)","IgG GMC",[17,19,20,23,26,28,31,34,35,36,38,39,40,44],{"measure":10,"description":11,"timeFrame":18},"30 days after booster vaccination",{"measure":14,"description":15,"timeFrame":18},{"measure":21,"description":22,"timeFrame":12},"Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8","Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8",{"measure":24,"description":25,"timeFrame":12},"Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)","Pneumococcal serotype-specific OPA antibody GMT",{"measure":27,"description":27,"timeFrame":12},"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg\u002FmL",{"measure":29,"description":30,"timeFrame":12},"Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)","Pneumococcal serotype-specific IgG GMI",{"measure":32,"description":33,"timeFrame":12},"Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)","Pneumococcal serotype-specific OPA antibody GMI",{"measure":27,"description":27,"timeFrame":18},{"measure":29,"description":30,"timeFrame":18},{"measure":37,"description":37,"timeFrame":18},"Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)",{"measure":24,"description":25,"timeFrame":18},{"measure":32,"description":33,"timeFrame":18},{"measure":41,"description":42,"timeFrame":43},"Safety of Sinovac PCV13","Incidence of adverse reactions","0-30 days within each dose",{"measure":41,"description":45,"timeFrame":46},"Incidence of serious adverse events","6 months within final dose",[48,51,52,54,58],{"measure":49,"description":49,"timeFrame":50},"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg\u002FmL (seropositive rate)","1,2,3 years after final dose",{"measure":27,"description":27,"timeFrame":50},{"measure":53,"description":53,"timeFrame":50},"Pneumococcal serotype-specific IgG geometric mean concentration (GMC)",{"measure":55,"description":56,"timeFrame":57},"Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)","Proportion of participants aged 2-5 years with pneumococcal serotype-specific OPA titers ≥ 1:8","1,2,3 years after vaccination",{"measure":59,"description":60,"timeFrame":57},"Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT) in participants aged 2-5 years","Pneumococcal serotype-specific OPA antibody GMT in participants aged 2-5 years",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":64,"timePerspective":64,"maskingInfo":66},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":67,"maskingDescription":64,"whoMasked":68},"QUADRUPLE",[69,70,71,72],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","A phase Ⅲ clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.",[75,81],{"label":76,"type":77,"description":78,"interventionNames":79},"Experimental: Sinovac PCV13","EXPERIMENTAL","Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.",[80],"Biological: Sinovac PCV13",{"label":82,"type":83,"description":84,"interventionNames":85},"Active Comparator: Prevnar®","ACTIVE_COMPARATOR","Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.",[86],"Biological: Prevnar®",[88,93],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":64},"BIOLOGICAL","Sinovac PCV13","One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.",[76],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":64},"Prevnar®","One dose of Prevnar® (0.5 mL) is administered intramuscularly.",[82],[98],{"name":99,"affiliation":100,"role":101},"Yanxia Wang","Henan Provincial Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[103,107],{"name":99,"role":104,"phone":105,"phoneExt":64,"email":106},"CONTACT","13613816598","wangyanxia99@163.com",{"name":108,"role":104,"phone":109,"phoneExt":64,"email":110},"Xiaoqiang Liu","15911568282","lxq7611@126.com",[112],{"facility":100,"status":113,"city":114,"state":115,"zip":64,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":124},"RECRUITING","Zhengzhou","Henan","China","CN",{"type":119,"coordinates":120},"Point",[121,122],113.64861,34.75778,{"lat":122,"lon":121},[125],{"name":99,"role":104,"phone":105,"phoneExt":64,"email":64},{"type":127,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100563557",false,"NCT06617715","Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine","A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants","Inclusion Criteria:\n\n1. Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);\n2. Participants' guardians provide legal identity document and participants' vaccination record;\n3. Participants' guardians understand and voluntarily sign the informed consent form;\n4. Participants' guardians can follow all study procedures and stay in contact during the study.\n\nExclusion Criteria:\n\n1. Received any pneumococcal vaccine prior to enrollment;\n2. History of bacterial pneumonia or invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae, as confirmed by laboratory tests;\n3. History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and abdominal pain;\n4. History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;\n5. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;\n6. Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);\n7. Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.\n8. Have\u002Fhave suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.\n9. History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;\n10. Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.\n11. Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years.\n12. Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.\n13. Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs during the study;\n14. Received live attenuated vaccine within 14 days prior to enrollment;\n15. Received subunit or inactivated or other vaccine within 7 days prior to enrollment;\n16. Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment;\n17. Had fever (axillary temperature≥ 37.3 Degree Celsius) before vaccination;\n18. In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial.",true,"ALL","6 Weeks","5 Years",{"count":139,"type":140},3080,"ESTIMATED","INTERVENTIONAL",[143],"PHASE3","A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.",[146],"Pneumococcal Infectious Disease","2026-01-26",{"date":149,"type":150},"2026-01-28","ACTUAL",{"date":152,"type":150},"2024-10-23",{"date":154,"type":140},"2026-07-30",{"name":156,"class":6},"Sinovac Life Sciences Co., Ltd.",1]