Nctid:
NCT06617715
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000011008", "term"=>"Pneumococcal Infections"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000013290", "term"=>"Streptococcal Infections"}, {"id"=>"D000016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D000001424", "term"=>"Bacterial Infections"}, {"id"=>"D000001423", "term"=>"Bacterial Infections and Mycoses"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infectious Disease", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infectious Disease", "relevance"=>"HIGH"}, {"id"=>"M13898", "name"=>"Pneumococcal Infections", "asFound"=>"Pneumococcal Infectious Disease", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M16080", "name"=>"Streptococcal Infections", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000069443", "term"=>"Heptavalent Pneumococcal Conjugate Vaccine"}], "ancestors"=>[{"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M412", "name"=>"Heptavalent Pneumococcal Conjugate Vaccine", "asFound"=>"RAD", "relevance"=>"HIGH"}, {"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Open-label for infants aged 3 months; Quadruple for other age groups."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>3975}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-12", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-04-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-26", "studyFirstSubmitQcDate"=>"2024-09-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)", "timeFrame"=>"1,2,3 years after final dose", "description"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 0.35 μg/mL (seropositive rate)"}, {"measure"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL", "timeFrame"=>"1,2,3 years after final dose", "description"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL"}, {"measure"=>"Pneumococcal serotype-specific IgG geometric mean concentration (GMC)", "timeFrame"=>"1,2,3 years after final dose", "description"=>"Pneumococcal serotype-specific IgG geometric mean concentration (GMC)"}], "primaryOutcomes"=>[{"measure"=>"Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)", "timeFrame"=>"30 days after primary vaccination", "description"=>"Proportion of serotype-specific IgG concentration ≥0.35 μg/ml"}, {"measure"=>"Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)", "timeFrame"=>"30 days after primary vaccination", "description"=>"IgG GMC"}], "secondaryOutcomes"=>[{"measure"=>"Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)", "timeFrame"=>"30 days after booster vaccination", "description"=>"Proportion of serotype-specific IgG concentration ≥0.35 μg/ml"}, {"measure"=>"Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)", "timeFrame"=>"30 days after booster vaccination", "description"=>"IgG GMC"}, {"measure"=>"Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8", "timeFrame"=>"30 days after primary vaccination", "description"=>"Proportion of participants with pneumococcal serotype-specific OPA antibody titers ≥ 1:8"}, {"measure"=>"Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)", "timeFrame"=>"30 days after primary vaccination", "description"=>"Pneumococcal serotype-specific OPA antibody GMT"}, {"measure"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL", "timeFrame"=>"30 days after primary vaccination", "description"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL"}, {"measure"=>"Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)", "timeFrame"=>"30 days after primary vaccination", "description"=>"Pneumococcal serotype-specific IgG GMI"}, {"measure"=>"Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)", "timeFrame"=>"30 days after primary vaccination", "description"=>"Pneumococcal serotype-specific OPA antibody GMI"}, {"measure"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL", "timeFrame"=>"30 days after booster vaccination", "description"=>"Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL"}, {"measure"=>"Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)", "timeFrame"=>"30 days after booster vaccination", "description"=>"Pneumococcal serotype-specific IgG GMI"}, {"measure"=>"Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)", "timeFrame"=>"30 days after booster vaccination", "description"=>"Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)"}, {"measure"=>"Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)", "timeFrame"=>"30 days after booster vaccination", "description"=>"Pneumococcal serotype-specific OPA antibody GMT"}, {"measure"=>"Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)", "timeFrame"=>"30 days after booster vaccination", "description"=>"Pneumococcal serotype-specific OPA antibody GMI"}, {"measure"=>"Safety of Sinovac PCV13", "timeFrame"=>"0-30 days within each dose", "description"=>"Incidence of adverse reactions"}, {"measure"=>"Safety of Sinovac PCV13", "timeFrame"=>"6 months within final dose", "description"=>"Incidence of serious adverse events"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pneumococcal Infectious Disease"]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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 combined with open-labelled 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 3975 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 except for infants aged 3 months. Infants aged 3 months will receive Sinovac PCV13."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"5 years", "minimumAge"=>"6 weeks", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Healthy infants or children who are aged 2 months (at least 6 weeks), 3 months, 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/have 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 3 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 3 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."}, "identificationModule"=>{"nctId"=>"NCT06617715", "briefTitle"=>"Phase Ⅲ Clinical Trial of 13-Valent Pneumococcal Conjugate Vaccine", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Sinovac Biotech Co., Ltd"}, "officialTitle"=>"A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants", "orgStudyIdInfo"=>{"id"=>"PRO-PCV-3001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Experimental Group", "description"=>"Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.", "interventionNames"=>["Biological: Sinovac PCV13"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Active Comparator Group", "description"=>"Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.", "interventionNames"=>["Biological: Prevnar®"]}], "interventions"=>[{"name"=>"Sinovac PCV13", "type"=>"BIOLOGICAL", "description"=>"One dose of Sinovac PCV13 (0.5 mL) is administered intramuscularly.", "armGroupLabels"=>["Experimental Group"]}, {"name"=>"Prevnar®", "type"=>"BIOLOGICAL", "description"=>"One dose of Prevnar® (0.5 mL) is administered intramuscularly.", "armGroupLabels"=>["Active Comparator Group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Yanxia Wang", "role"=>"CONTACT", "email"=>"wangyanxia99@163.com", "phone"=>"13613816598"}, {"name"=>"Xiaoqiang Liu", "role"=>"CONTACT", "email"=>"lxq7611@126.com", "phone"=>"15911568282"}], "overallOfficials"=>[{"name"=>"Yanxia Wang", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Henan Provincial Center for Disease Control and Prevention"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sinovac Life Sciences Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
