[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562034":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1-3 (2 times verum)","EXPERIMENTAL","Group 1-3 receive 2 doses of the RSV vaccine at visit 1 and visit 3, 1-2 months apart.",[13],"Biological: Arexvy powder and suspension for injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 4 (1 time verum, 1 time placebo, randomised)","PLACEBO_COMPARATOR","Group 4 receives 1 doses of the RSV vaccine or placebo at visit 1 and visit 3.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Arexvy powder and suspension for injection","Arexvy powder and suspension for injection (RSV vaccine)",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Angelika Wagner, MD, PhD","CONTACT","+43 1 40160 38276","angelika.wagner@meduniwien.ac.at",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"Ines Zwazl, MSc","0043 1 40160 38276","ines.zwazl@meduniwien.ac.at",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Institute of Specific Prophylaxis and Tropical Medicine, CePII, Medical university of Vienna","RECRUITING","Vienna","1090","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],16.37208,48.20849,{"lat":48,"lon":47},[51,54,56],{"name":28,"role":29,"phone":52,"phoneExt":53,"email":31},"+43 1 40160","38201",{"name":33,"role":29,"phone":52,"phoneExt":55,"email":35},"38276",{"name":28,"role":29,"phone":25,"phoneExt":25,"email":25},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Angelika Wagner","Principal Investigator",[62],{"name":63,"class":64},"GlaxoSmithKline","INDUSTRY","100562034","phase-2-rsv-vaccination-in-immunocompromised-patients-100562034",false,"NCT06597916","RSV Vaccination in Immunocompromised Patients.","A Phase-2b Controlled Study to Evaluate the Humoral and Cellular Immune Response and Safety Following One and Two Doses of an Adjuvanted RSV Subunit Vaccine in Immunocompromised Patients Aged 18 Years and Older.","General inclusion criteria\n\n1. Participants who, in the opinion of the investigator, can understand and will comply with the requirements of the protocol.\n2. Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.\n3. Participants who can give written informed consent prior to study entry and performance of any study-specific procedure.\n4. Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, post-menopause, premenarche, bilateral oophorectomy, or bilateral salpingectomy\n5. Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to first Arexvy vaccination and agreed to continue adequate contraception for at least 1 month after completion of the last study intervention administration, and has a negative pregnancy test on the day of first vaccination prior to vaccine application.\n6. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable.\n7. Additional inclusion criteria for \"group 1\":\n\n   7.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 7.2. Diagnosis of a hemato-oncological disease: multiple myeloma including early stage disease or lymphoma in participants medically stable in the opinion of the investigator at study inclusion.\n\n   7.3. Participants without SCT or ≥3 months after autologous SCT until 24 months after SCT. SCT \\>24 months, if they have ongoing immunomodulatory\u002Fsuppressive treatment.\n\n   7.4. Immunosuppressive or modulating medication related to the hemato-oncological disease are allowed.\n8. Additional inclusion criteria for \"group 2\":\n\n   8.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 8.2. Diagnosis of lung cancer ≥ stage 1. 8.3. Ongoing cancer treatment (including chemotherapy and immunotherapy) or initiation planned within 14 days and treatment initiation\u002Fvaccinations preferentially scheduled between treatment cycles.\n9. Additional inclusion criteria for \"group 3\":\n\n   9.1. Age ≥18 years at the time of signing the Informed consent form (ICF). 9.2. Diagnosis of an autoimmune\u002Fchronic inflammatory disease with chronic inflammatory bowel disease (IBD) or rheumatoid arthritis (RA).\n\n   9.3. Treatment with biologicals such as TNF-alpha blocker, anti-CD20, JAK-inhibitors or other biological treatment (combinations with DMARDs, immunomodulators or steroidal or non-steroidal anti-inflammatory drugs are allowed).\n\n   9.4. Stable disease at time of study entry.\n10. Additional inclusion criteria for \"group 4\":\n\n10.1. Age ≥60 years at the time of signing the Informed consent form (ICF). 10.2. Healthy, as established by medical history before entering the study with medically stable\u002Fcontrolled chronic conditions such as diabetes, hypertension or cardiac disease allowed.",true,"ALL","18 Years",{"count":76,"type":77},200,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn\u002Fwinter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific.\n\nThe study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.",[83],"RSV Infection",[85,86,87,88,89,90,91],"RSV prophylaxis","RSV vaccine","RSV vaccination","RSV immunocompromised","RSV multiple myeloma","RSV lung cancer","RSV IBD","2024-11-25",{"date":94,"type":95},"2024-11-27","ACTUAL",{"date":97,"type":95},"2024-09-19",{"date":99,"type":77},"2026-03-31",{"name":5,"class":6},1]