[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590427":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":29,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":29,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":29,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose","EXPERIMENTAL","The experimental vaccine will be administered in three doses, with a 28-day interval between each dose.",[13],"Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine",{"label":15,"type":10,"description":11,"interventionNames":16},"High dose",[13],{"label":18,"type":19,"description":20,"interventionNames":21},"Control","ACTIVE_COMPARATOR","The controlled vaccine will be administered in three doses, with a 28-day interval between each dose.",[22],"Biological: Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)",[24,30,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BIOLOGICAL","Oral hexavalent reassortant rotavirus attenuated live vaccine","Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally",[9],null,{"type":25,"name":26,"description":31,"armGroupLabels":32,"otherNames":29},"Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)","The controlled vaccine three doses administered orally",[18],[38],{"name":39,"role":40,"phone":41,"phoneExt":29,"email":42},"Yeqing Tong","CONTACT","+86-13971078410","63382251@qq.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hubei Provincial Center for Disease Control and Prevention","RECRUITING","Wuhan","Hubei","430079","China","CN",{"type":53,"coordinates":54},"Point",[55,56],114.26667,30.58333,{"lat":56,"lon":55},[59],{"name":39,"role":40,"phone":41,"phoneExt":29,"email":42},{"type":61,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100590427","phase-2-phaseclinical-trial-of-oral-hexavalent-reassortant-rotavirus-attenuated-live-vaccine-vero-cells-100590427",false,"NCT06967272","PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)","Evaluating the Immunogenicity and Safety of the Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) in Healthy Infants Via a Randomized, Double-blind, Active-controlled Phase II Clinical Trial.","Inclusion Criteria:\n\n1. Healthy infants aged 6 to 12 weeks.\n2. The legal guardian(s) is\u002Fare capable of understanding and voluntarily signing the informed consent form.\n3. The legal guardian(s) is\u002Fare willing and able to comply with all follow-up visits, sample collection, vaccination, and other study procedures.\n4. Able to provide valid legal identification documents.\n\nExclusion Criteria:\n\n1. Previous vaccination with any rotavirus vaccine.\n2. History of rotavirus infection.\n3. Gestational age \\\u003C37 weeks or ≥42 weeks at birth.\n4. History of dystocia, neonatal asphyxia requiring resuscitation, or neurological impairment at birth.\n5. Known hypersensitivity to any vaccine component (e.g., urticaria, dyspnea, angioedema).\n6. Current diarrhea, vomiting, or other gastrointestinal disorders; gastroenteritis or any acute\u002Fchronic illness exacerbation within 7 days prior to vaccination; ongoing antibiotic\u002Fantiviral therapy.\n7. History of intussusception or chronic gastrointestinal diseases, including congenital malformations predisposing to intussusception (e.g., Meckel's diverticulum).\n8. Congenital malformations, developmental disorders, genetic defects, severe malnutrition, malignancies, or significant chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome).\n9. Autoimmune or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection).\n10. Household members with immunodeficiency\u002Fimmunosuppression or undergoing\u002Fscheduled for immunosuppressive\u002Fcytotoxic therapy.\n11. Coagulation disorders (e.g., clotting factor deficiencies, platelet abnormalities).\n12. Immunosuppressive therapy for ≥14 days post-birth (prednisone ≥2mg\u002Fkg\u002Fday or equivalent), immunomodulatory\u002Fcytotoxic therapy, or planned use during the study.\n13. History of severe neurological\u002Fpsychiatric disorders (e.g., epilepsy, non-febrile seizures, convulsions) or relevant family history.\n14. Postnatal administration of immunoglobulins\u002Fblood products (except hepatitis B immunoglobulin) or planned use during the study.\n15. Previous participation in other investigational drug\u002Fvaccine studies or planned use during this study.\n16. Receipt of live-attenuated vaccines within 14 days or subunit\u002Finactivated vaccines within 7 days prior to enrollment.\n17. Axillary temperature ≥38.0°C within the past 3 days.\n18. Fever on scheduled vaccination day (axillary temperature \\>37.0°C; measured ≥30 minutes post-feeding).\n19. Currently or planning to participate in other vaccine or drug clinical trials.\n20. Any other factors that the investigator deems unsuitable for participation in the clinical trial.",true,"ALL","6 Weeks","12 Weeks",{"count":74,"type":75},400,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The Phase II clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in infants aged 6 to 12 weeks. This study will evaluate the immunogenicity and safety of the investigational vaccine in healthy infants through a randomized, double-blind, active-controlled trial.",[81],"Rotavirus Gastroenteritis",[83,84,85,86,87,88],"Phase II","Immunogenicity","Safety","Randomized Controlled Trial","Rotavirus gastroenteritis","Vaccine","2025-08-18",{"date":91,"type":92},"2025-08-22","ACTUAL",{"date":94,"type":92},"2025-01-20",{"date":96,"type":75},"2026-11-15",{"name":98,"class":6},"Sinovac Life Sciences Co., Ltd.",1]