[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646067":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Serum Institute of India Pvt. Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Recombinant Poliomyelitis Vaccine (rPV)","EXPERIMENTAL",null,[13],"Biological: Recombinant Poliomyelitis Vaccine (rPV)",{"label":15,"type":16,"description":11,"interventionNames":17},"Inactivated Poliomyelitis Vaccine (IPOL)","ACTIVE_COMPARATOR",[18],"Biological: Inactivated Poliomyelitis Vaccine (IPOL)",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"BIOLOGICAL","Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"IPOL (inactivated poliovirus vaccine) is a marketed Sanofi",[15],[28],{"name":29,"affiliation":5,"role":30},"Dr Hitt Sharma, MBBS MBA","STUDY_DIRECTOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":11,"email":35},"CONTACT","+91-9822418354","drhjs@seruminstitute.com",{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},"Dr Sameer Parekh, MBA","+91-9226722745","sameer.parekh@seruminstitute.com",[41],{"facility":42,"status":11,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Doherty Clinical Trials Limited","East Melbourne","Victoria","3002","Australia","AU",{"type":49,"coordinates":50},"Point",[51,52],144.9879,-37.81667,{"lat":52,"lon":51},[55,59],{"name":56,"role":33,"phone":57,"phoneExt":11,"email":58},"Nicola Byrne","+61 03 9970 4200","nbyrne@dohertyclinicaltrials.com",{"name":60,"role":61,"phone":11,"phoneExt":11,"email":11},"Dr Gail Cross, MBBS FRACP PhD","PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100646067","phase-1-safety-and-immunogenicity-of-a-recombinant-poliomyelitis-vaccine-rpv-in-comparison-with-ipol-vaccine-in-healthy-adults-100646067",false,"NCT07688369","Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults","A Phase 1, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults","Key Inclusion Criteria:\n\n* Healthy Volunteers aged between 18 to 60 years inclusive.\n* Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator.\n* Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30..\n* Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit.\n* Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit.\n\nKey Exclusion Criteria:\n\n* History of Polio\n* Any vaccination received 30 days before Screening and Day 30\n* Pregnant or lactating females\n* BMI \\>35.0kg\u002Fm2\n* History of alcohol abuse or drug addiction\n* Have received any polio vaccines within 6 months prior to screening.\n* History of major surgeries\n* History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination\n* any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.",true,"ALL","18 Years","60 Years",{"count":76,"type":77},36,"ESTIMATED","INTERVENTIONAL",[80],"PHASE1","The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).",[83],"Polio Immunity",[85],"recombinant, polio","NOT_YET_RECRUITING","2026-07-09",{"date":89,"type":90},"2026-07-10","ACTUAL",{"date":92,"type":77},"2026-07",{"date":94,"type":77},"2027-03",{"name":5,"class":6},1]