[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563557":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Sinovac PCV13","EXPERIMENTAL","Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.",[13],"Biological: Sinovac PCV13",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Prevnar®","ACTIVE_COMPARATOR","Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.",[19],"Biological: Prevnar®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Sinovac PCV13","One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prevnar®","One dose of Prevnar® (0.5 mL) is administered intramuscularly.",[15],[32],{"name":33,"affiliation":34,"role":35},"Yanxia Wang","Henan Provincial Center for Disease Control and Prevention","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","13613816598","wangyanxia99@163.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Xiaoqiang Liu","15911568282","lxq7611@126.com",[46],{"facility":34,"status":47,"city":48,"state":49,"zip":26,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Zhengzhou","Henan","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.64861,34.75778,{"lat":56,"lon":55},[59],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100563557","phase-3-clinical-trial-of-13-valent-pneumococcal-conjugate-vaccine-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":74,"type":75},3080,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81],"Pneumococcal Infectious Disease","2026-01-26",{"date":84,"type":85},"2026-01-28","ACTUAL",{"date":87,"type":85},"2024-10-23",{"date":89,"type":75},"2026-07-30",{"name":91,"class":6},"Sinovac Life Sciences Co., Ltd.",1]