[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100168027":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":25,"responsibleParty":26,"collaborators":25,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":25,"eligibilityCriteria":34,"healthyVolunteers":35,"sex":36,"minAge":37,"maxAge":25,"enrollmentInfo":38,"targetDuration":25,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":25},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"V212","EXPERIMENTAL","Participants receive V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.",[13],"Biological: V212",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","V212 viral antigen for HZ",[9],[20],"Inactivated Varicella-Zoster (VZV) vaccine",[22],{"name":23,"affiliation":5,"role":24},"Medical Director","STUDY_DIRECTOR",null,{"type":27,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100168027","phase-1-a-study-to-evaluate-the-safety-and-immunogenicity-of-inactivated-varicella-zoster-virus-vzv-vaccine-in-adults-with-hematologic-malignancies-hm-receiving-treatment-with-anti-cluster-of-differentiation-cd-20-monoclonal-antibodies-v212-013-100168027",true,"NCT01460719","A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)","A Phase I, Open-Label, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212\u002FInactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies Receiving Treatment With Anti-CD20 Monoclonal Antibodies","Inclusion Criteria:\n\n* Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies and is not likely to undergo hematopoietic cell transplant (HCT).\n* Has a predicted life expectancy of ≥ 12 months.\n* Has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.\n* All female participants of childbearing potential must have a negative serum or urine pregnancy test.\n\nExclusion Criteria:\n\n* A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic\u002Fanaphylactoid reaction to neomycin.\n* Prior history of HZ within 1 year of enrollment.\n* Prior receipt of any varicella or zoster vaccine.\n* Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.\n* Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.\n* Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.\n* Participant is currently participating or has participated in a study with an investigational anti-CD20 monoclonal antibody within 3 months of signing informed consent.",false,"ALL","18 Years",{"count":39,"type":40},80,"ACTUAL","INTERVENTIONAL",[43],"PHASE1","An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at \\~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is \\>1.0.",[46],"Herpes Zoster","COMPLETED","2018-11-15",{"date":50,"type":40},"2019-03-11",{"date":52,"type":40},"2012-01-24",{"date":54,"type":40},"2012-09-25",{"name":5,"class":6}]