[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100363302":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":39,"locations":49,"responsibleParty":66,"collaborators":68,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":11,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":11,"overallStatus":94,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"PATH","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TV P2-VP8","EXPERIMENTAL",null,[13],"Biological: TV P2-VP8",{"label":15,"type":16,"description":11,"interventionNames":17},"Rotarix®","ACTIVE_COMPARATOR",[18],"Biological: Rotarix",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"BIOLOGICAL","90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Rotarix","Rotarix® PO plus IM placebo administered on study days 1, 29 and 57",[15],[29,33,36],{"name":30,"affiliation":31,"role":32},"George Armah, PhD","Noguchi Memorial Institute for Medical Research, University of Ghana, Legon","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Desiree Witte, MD","Malawi-Liverpool-Wellcome Trust (MLW) Clinical Research Programme",{"name":37,"affiliation":38,"role":32},"Roma Chilengi, MD","Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Joanne Csedrik, RN, MPH","CONTACT","+1-202-540-4496","jcsedrik@path.org",{"name":46,"role":42,"phone":47,"phoneExt":11,"email":48},"Tushar Tewari, MD","+91-11-40640005","ttewari@path.org",[50],{"facility":51,"status":52,"city":53,"state":11,"zip":11,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Centre for Infectious Disease Research in Zambia (CIDRZ)","RECRUITING","Lusaka","Zambia","ZM",{"type":57,"coordinates":58},"Point",[59,60],28.28713,-15.40669,{"lat":60,"lon":59},[63,64],{"name":37,"role":42,"phone":11,"phoneExt":11,"email":11},{"name":65,"role":42,"phone":11,"phoneExt":11,"email":11},"Caroline Chisenga, PhD",{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[69,71],{"name":70,"class":6},"Bill and Melinda Gates Foundation",{"name":72,"class":73},"SK Bioscience Co., Ltd.","INDUSTRY","100363302","phase-3-a-trial-to-assess-the-safety-immunogenicity-and-efficacy-of-a-trivalent-rotavirus-p2-vp8-subunit-vaccine-in-prevention-of-severe-rotavirus-gastroenteritis-in-healthy-infants-in-africa-and-india-100363302",false,"NCT04010448","A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants in Africa and India","A Phase 3 Double-blind, Randomized, Active Comparator-controlled, Group-sequential, Multinational Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention of Severe Rotavirus Gastroenteritis in Healthy Infants","Inclusion Criteria:\n\n* Healthy infants as established by medical history and clinical examination before entering the study\n* Age: ≥6 and \\\u003C8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old)\n* Parental\u002Flegal guardian's ability and willingness to provide written informed consent\n* Intention of the participants' parents to remain in the area with the child during the study period\n\nExclusion Criteria:\n\n* Acute disease at the time of first study vaccination - temporary exclusion\n* Presence of fever on the day of first study vaccination (axillary temperature \\>37.6oC) - temporary exclusion\n* Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw)\n* Presence of severe malnutrition (weight-for-height z-score ≤-3SD median, per WHO published child growth standards) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and\u002For physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol\n* History of premature birth (\\\u003C37 weeks gestation) and\u002For birth weight of \\\u003C2.5 kg\n* History of congenital abdominal disorders, intussusception, or abdominal surgery\n* Prior receipt of rotavirus vaccine\n* Known sensitivity or allergy to any components of the study vaccine\n* Contraindication to any EPI\u002FUIP vaccine\n* History of anaphylactic reaction\n* Major congenital or genetic defect\n* Parents not able, available or willing to accept active weekly follow-up by the study staff\n* Receipt of any immunoglobulin therapy and\u002For blood products\n* Nursing infants whose mother are receiving immunosuppressive biologicals\n* History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study)\n* Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents' ability to give informed consent",true,"ALL","6 Weeks","8 Weeks",{"count":86,"type":87},8200,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8\u002Fplacebo IM and two doses of Rotarix®\u002Fplacebo PO at monthly intervals starting at ≥6 to \\\u003C8 weeks of age, administered concomitantly with EPI\u002FUIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.",[93],"Rotavirus Infection of Children","UNKNOWN","2021-04-08",{"date":97,"type":98},"2021-04-09","ACTUAL",{"date":100,"type":98},"2019-10-10",{"date":102,"type":87},"2025-12-15",{"name":5,"class":6},1]