[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100251834":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":25,"locations":25,"responsibleParty":35,"collaborators":37,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":25,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":25,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"U.S. Army Medical Research and Development Command","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Killed ETEC\u002FrCTB vaccine","EXPERIMENTAL","Three doses administered orally at 2-week intervals",[13],"Biological: ETEC\u002FrCTB vaccine",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","ETEC\u002FrCTB vaccine","Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10\\^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg)",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":29,"otherNames":25},"OTHER","Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10\\^11 heat-killed bacteria per dose)",[15],[31],{"name":32,"affiliation":33,"role":34},"Stephen Savarino, MD, MPH","Naval Medical Research Center","PRINCIPAL_INVESTIGATOR",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[38,41,44,47,49],{"name":39,"class":40},"U.S. Naval Medical Research Unit No. 3","UNKNOWN",{"name":42,"class":43},"Ministry of Health and Population, Egypt","OTHER_GOV",{"name":45,"class":46},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":48,"class":27},"International Vaccine Institute",{"name":50,"class":27},"Göteborg University","100251834","phase-3-efficacy-of-an-oral-killed-enterotoxigenic-escherichia-coli-vaccine-in-prevention-of-diarrhea-in-egyptian-infants-and-young-children-100251834",false,"NCT02556996","Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children","Inclusion Criteria:\n\n1. Willingness of parent to have the child participate;\n2. Plans to reside in catchment area continuously for at least one year\n\nExclusion Criteria:\n\n1. Global developmental delay\n2. Severe malnutrition\n3. Chronic bedridden status\n4. Serious chronic disorder requiring chronic medication",true,"ALL","6 Months","18 Months",{"count":62,"type":63},356,"ACTUAL","INTERVENTIONAL",[66],"PHASE3","This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over a one year period of follow-up by active surveillance. The vaccine consists of a mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and recombinant cholera toxin B-subunit (killed ETEC\u002FrCTB vaccine). The placebo preparation is heat-killed Escherichia coli K-12 bacteria.",[69],"Diarrhea","COMPLETED","2015-10-07",{"date":73,"type":74},"2015-10-12","ESTIMATED",{"date":76,"type":25},"1998-10",{"date":78,"type":63},"2002-04",{"name":5,"class":6}]