Nctid:
NCT06614816
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002644", "term"=>"Chickenpox"}], "ancestors"=>[{"id"=>"D000073618", "term"=>"Varicella Zoster Virus Infection"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M5888", "name"=>"Chickenpox", "asFound"=>"Chickenpox", "relevance"=>"HIGH"}, {"id"=>"M9640", "name"=>"Herpes Zoster", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M1200", "name"=>"Varicella Zoster Virus Infection", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "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"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-02-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2022-06-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-08", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-07-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"seroconversion rate", "timeFrame"=>"42 days after completing the full course of vaccination.", "description"=>"The primary immunogenicity endpoint was the seroconversion rate of VZV antibodies"}], "secondaryOutcomes"=>[{"measure"=>"geometric mean titer (GMT)", "timeFrame"=>"42 days after completing the full course of vaccination.", "description"=>"geometric mean titer (GMT) of VZV antibodies 42 days after vaccination"}, {"measure"=>"geometric mean fold increase (GMFI)", "timeFrame"=>"42 days after completing the full course of vaccination.", "description"=>"geometric mean fold increase (GMFI) of VZV antibodies 42 days after vaccination"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Chickenpox Vaccines"]}, "descriptionModule"=>{"briefSummary"=>"Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years: A Phase III, Randomized, Double-Blind, Active-Controlled Study"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"12 years", "minimumAge"=>"1 year", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Ages ranging from 1 to 12 years for the general healthy population ;\n* Obtain informed consent from the volunteer and/or their legal guardian, and sign the informed consent form;\n* The volunteer and/or their legal guardian is able to comply with the requirements of the clinical trial protocol;\n* Axillary body temperature ≤37.0℃.\n\nExclusion Criteria:\n\n* Those who have previously been vaccinated against varicella, have a history of varicella or herpes zoster infection;\n* Allergy to known components of the study vaccine, or a history of severe allergic reactions to any vaccination;\n* A history of epilepsy, seizures, or convulsions, or a family history of psychiatric disorders;\n* Individuals with immunodeficiency, undergoing immunosuppressive therapy (e.g., oral corticosteroids), or HIV-related immunocompromised individuals, or those with family members closely exposed to congenital immune diseases;\n* Those with congenital malformations, developmental disorders, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome);\n* Known or suspected concurrent diseases, including respiratory diseases, acute infections, or active chronic diseases, cardiovascular diseases, skin diseases, severe hypertension, or during treatment for malignant tumors;\n* Diagnosed with coagulation dysfunction (e.g., deficiency of coagulation factors, coagulation disorders, platelet abnormalities) or significant bruising or coagulation disorders;\n* Receipt of blood products within the past 3 months;\n* Receipt of attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days;\n* Acute illnesses or acute exacerbations of chronic diseases in the past 7 days;\n* A history of high fever (axillary body temperature ≥38.0℃) within the past 3 days;\n* Any other factors deemed by the investigator as unsuitable for participation in the clinical trial."}, "identificationModule"=>{"nctId"=>"NCT06614816", "briefTitle"=>"Immunogenicity and Safety of a Live Attenuated Varicella Vaccine in Children Aged 1-12 Years", "organization"=>{"class"=>"OTHER", "fullName"=>"Southeast University, China"}, "officialTitle"=>"Phase III Clinical Trial of Lyophilized Live Attenuated Varicella Vaccine for Children Aged 1-12 Years", "orgStudyIdInfo"=>{"id"=>"JSVCT057"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Live Attenuated Varicella vaccine candidates", "description"=>"The test group received the freeze-dried live attenuated VarV developed by Beijing Minhai Biotechnology Co., LTD., which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cells inoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.", "interventionNames"=>["Biological: Oka strain varicella attenuated live vaccine"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Marketed Live Attenuated Varicella vaccine", "description"=>"the active control group received VarV produced by Changchun BCHT Biotechnology Co.,which are derived from the Oka strain, cultured and harvested from inoculated MRC-5 human diploid cellsinoculated human diploid cells (MRC-5), and then lyophilized with appropriate stabilizers.", "interventionNames"=>["Biological: Oka strain varicella attenuated live vaccine"]}], "interventions"=>[{"name"=>"Oka strain varicella attenuated live vaccine", "type"=>"BIOLOGICAL", "description"=>"lyophilized powder, subcutaneous injection", "armGroupLabels"=>["Live Attenuated Varicella vaccine candidates", "Marketed Live Attenuated Varicella vaccine"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"223399", "city"=>"Huaian", "state"=>"Jiangsu", "country"=>"China", "facility"=>"Huaiyin District Center for Disease Control and Prevention", "geoPoint"=>{"lat"=>33.50389, "lon"=>119.14417}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Southeast University, China", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Jiangsu CDC", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"MD, Department of epidemiology and biostatistics, School of public health,", "investigatorFullName"=>"Shiyuan Wang", "investigatorAffiliation"=>"Southeast University, China"}}}}
