[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590427":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":55,"studyPopulation":43,"armGroups":56,"interventions":72,"overallOfficials":43,"centralContacts":85,"locations":91,"responsibleParty":108,"collaborators":43,"id":110,"slug":43,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":43,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":43,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":94,"whyStopped":43,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},{"fullName":5,"class":6},"Sinovac Biotech Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":43},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluate the immunogenicity of the investigational vaccine at different doses","The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum","28 days after the full vaccination course",{"measure":14,"description":15,"timeFrame":16},"Evaluate the safety of the investigational vaccine at different dose","Incidence of adverse events\u002Freactions","0 day after the first dose till 42 days after the last dose",[18,20,22,24,27,28,30,32,35,38,40],{"measure":10,"description":19,"timeFrame":12},"The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies",{"measure":10,"description":21,"timeFrame":12},"The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies",{"measure":10,"description":23,"timeFrame":12},"The geometric mean increase (GMI) of serum anti-vaccine-type rotavirus IgA antibodies",{"measure":25,"description":21,"timeFrame":26},"Evaluate the immunogenicity persistence of the investigational vaccine at different doses","12 months after the full vaccination course",{"measure":25,"description":19,"timeFrame":26},{"measure":14,"description":15,"timeFrame":29},"0-30 minutes after each dose",{"measure":14,"description":15,"timeFrame":31},"0-14 days after each dose",{"measure":14,"description":33,"timeFrame":34},"Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)","The first dose to 12 months after full vaccination",{"measure":36,"description":37,"timeFrame":31},"Evaluate the fecal shedding of investigated vaccine strain after vaccination","The shedding rate of the rotavirus vaccine strain in the stool.",{"measure":36,"description":39,"timeFrame":31},"The shedding duration of the rotavirus vaccine strain in the stool.",{"measure":41,"description":42,"timeFrame":31},"Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples after vaccination","The incidence of reassortment and reversion of the rotavirus vaccine strain in stool samples.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":49,"maskingDescription":43,"whoMasked":50},"QUADRUPLE",[51,52,53,54],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The Phase II clinical trial is a randomized, double-blind, active-controlled study conducted in healthy infants to evaluate the immunogenicity and safety of the investigational vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The control vaccine is the orally administered pentavalent reassortant rotavirus attenuated live vaccine (Vero Cells) produced by Merck Sharp \\& Dohme Corp.\n\nThis study plans to recruit 400 infants aged 6 to 12 weeks. All participants will be randomly assigned to the low-dose investigational group, high-dose investigational group, and active-controlled group, respectively.The immunization schedule for both the investigational vaccine and controlled vaccine consists of three doses administered at 28-day intervals.\n\nBlood samples will be collected at predefined time points to evaluate the immunogenicity of the investigational vaccine. Adverse events (AEs) will be collected for all participants from the first vaccination until 42 days after the last dose, while serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored for 12 months.\n\nA safety monitoring sub-cohort will be established, with stool samples collected daily for 14 days after each vaccination to assess vaccine virus shedding, duration and patterns of viral shedding, potential reassortment and reversion to virulence of the rotavirus vaccine strains",[57,63,66],{"label":58,"type":59,"description":60,"interventionNames":61},"Low dose","EXPERIMENTAL","The experimental vaccine will be administered in three doses, with a 28-day interval between each dose.",[62],"Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine",{"label":64,"type":59,"description":60,"interventionNames":65},"High dose",[62],{"label":67,"type":68,"description":69,"interventionNames":70},"Control","ACTIVE_COMPARATOR","The controlled vaccine will be administered in three doses, with a 28-day interval between each dose.",[71],"Biological: Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)",[73,78,81],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":43},"BIOLOGICAL","Oral hexavalent reassortant rotavirus attenuated live vaccine","Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally",[58],{"type":74,"name":75,"description":79,"armGroupLabels":80,"otherNames":43},"Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally",[64],{"type":74,"name":82,"description":83,"armGroupLabels":84,"otherNames":43},"Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)","The controlled vaccine three doses administered orally",[67],[86],{"name":87,"role":88,"phone":89,"phoneExt":43,"email":90},"Yeqing Tong","CONTACT","+86-13971078410","63382251@qq.com",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Hubei Provincial Center for Disease Control and Prevention","RECRUITING","Wuhan","Hubei","430079","China","CN",{"type":101,"coordinates":102},"Point",[103,104],114.26667,30.58333,{"lat":104,"lon":103},[107],{"name":87,"role":88,"phone":89,"phoneExt":43,"email":90},{"type":109,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","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":121,"type":122},400,"ESTIMATED","INTERVENTIONAL",[125],"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.",[128],"Rotavirus Gastroenteritis",[130,131,132,133,134,135],"Phase II","Immunogenicity","Safety","Randomized Controlled Trial","Rotavirus gastroenteritis","Vaccine","2025-08-18",{"date":138,"type":139},"2025-08-22","ACTUAL",{"date":141,"type":139},"2025-01-20",{"date":143,"type":122},"2026-11-15",{"name":145,"class":6},"Sinovac Life Sciences Co., Ltd.",1]