[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629342":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":24,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":24,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":24,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sinovac (Dalian) Vaccine Technology Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No vaccination history group","EXPERIMENTAL","Participants aged 1-12 years with no vaccination history of varicella-containing vaccine",[13],"Biological: Varicella Vaccine",{"label":15,"type":10,"description":16,"interventionNames":17},"Vaccination history group","Participants aged 2-12 years have received 1 dose of varicella vaccine",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","Varicella Vaccine","Varicella vaccine manufactured by Sinovac",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Pham Thi Van Anh","CONTACT","+84- 915 595 690","phamthivananh.hmu@gmail.com",[32],{"facility":33,"status":24,"city":34,"state":24,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hanoi Medical University","Hanoi","100000","Vietnam","VN",{"type":39,"coordinates":40},"Point",[41,42],105.84117,21.0245,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100629342","phase-3-immunogenicity-and-safety-of-varicella-vaccine-live-in-healthy-vietnamese-children-100629342",false,"NCT07473427","Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children","Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial","Inclusion Criteria:\n\n1. Healthy children aged 1-12 years;\n2. Vaccination history:\n\n   * Participants aged 1 year old: no vaccination history with any varicella containing vaccine;\n   * Participants aged 2\\~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;\n3. Participants and\u002For their legal guardians are able to understand and sign the informed consent\u002Fassent voluntarily;\n4. Participants are able to comply with the study procedures based on the assessment of the investigator;\n5. Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.\n\nExclusion Criteria:\n\n1. Prior history of VZV infection;\n2. Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;\n3. Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;\n4. Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);\n5. Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;\n6. Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;\n7. Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;\n8. Current or history of severe neurological diseases (epilepsy, convulsions or seizures \\[excluding history of febrile seizures\\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;\n9. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg\u002Fday, or prednisone ≥2mg\u002Fkg\u002Fday, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;\n10. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;\n11. Receipt of other investigational drugs\u002Fvaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;\n12. Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;\n13. Fever on vaccination day, with axillary temperature \\>37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;\n14. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;\n15. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;\n16. Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.",true,"ALL","1 Year","12 Years",{"count":60,"type":61},300,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.",[67,68],"Varicella (Chickenpox)","Varicella Immunisation","NOT_YET_RECRUITING","2026-06-10",{"date":72,"type":73},"2026-06-12","ACTUAL",{"date":75,"type":61},"2026-06-15",{"date":77,"type":61},"2026-10-01",{"name":5,"class":6},1]