{"id":"fsme-immun-vaccine","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, redness, or swelling"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated whole virus particles that trigger both humoral (antibody) and cell-mediated immune responses against tick-borne encephalitis virus. This provides protection against infection when exposed to the virus through tick bites in endemic regions. The vaccine is typically administered in a series of doses to establish and maintain protective immunity.","oneSentence":"FSME-IMMUN is an inactivated tick-borne encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against TBEV.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:30:15.800Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of tick-borne encephalitis (TBE) in endemic areas"}]},"trialDetails":[{"nctId":"NCT06333275","phase":"","title":"Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy","status":"RECRUITING","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2023-11-14","conditions":"Vaccine Immunity in CAR-T Cell Therapy Recipients","enrollment":80},{"nctId":"NCT00840801","phase":"PHASE3","title":"Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-02-06","conditions":"Encephalitis, Tick-Borne","enrollment":302},{"nctId":"NCT04573205","phase":"PHASE4","title":"Primary TBE Vaccination for the Elderly","status":"UNKNOWN","sponsor":"Region Örebro County","startDate":"2024-01","conditions":"Tick-borne Encephalitis, Vaccine","enrollment":90},{"nctId":"NCT01991067","phase":"PHASE2","title":"Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2014-07","conditions":"Tick Borne Encephalitis","enrollment":34},{"nctId":"NCT02511535","phase":"PHASE4","title":"TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2013-09","conditions":"Vaccine Responsiveness in Allergy, Vaccine Responsiveness During Allergy De-sensitization Treatment","enrollment":119},{"nctId":"NCT04017052","phase":"PHASE4","title":"Application of a TBE-Vaccine in Obese Persons","status":"UNKNOWN","sponsor":"Medical University of Vienna","startDate":"2015-04-15","conditions":"Tick Borne Encephalitis","enrollment":73},{"nctId":"NCT01031537","phase":"PHASE2","title":"Vaccine Study for Tick-Borne Encephalitis Virus (TBEV)","status":"TERMINATED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2009-09-25","conditions":"Tick-Borne Encephalitis, Encephalitis, Tick-Borne, Tick-Borne Disease","enrollment":69},{"nctId":"NCT00161798","phase":"PHASE2","title":"Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2001-09","conditions":"Tick-borne Encephalitis","enrollment":""},{"nctId":"NCT00161824","phase":"PHASE3","title":"Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR","status":"COMPLETED","sponsor":"Pfizer","startDate":"2001-10","conditions":"Encephalitis, Tick-borne","enrollment":3800},{"nctId":"NCT00161772","phase":"PHASE2","title":"Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2002-03","conditions":"Tick-borne Encephalitis","enrollment":""},{"nctId":"NCT00161876","phase":"PHASE3","title":"FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years","status":"COMPLETED","sponsor":"Pfizer","startDate":"2002-05","conditions":"Encephalitis, Tick-borne","enrollment":3973},{"nctId":"NCT00161954","phase":"PHASE4","title":"Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years","status":"COMPLETED","sponsor":"Pfizer","startDate":"2004-03","conditions":"Encephalitis, Tick-borne","enrollment":""},{"nctId":"NCT00161850","phase":"PHASE2","title":"FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years","status":"COMPLETED","sponsor":"Pfizer","startDate":"2002-02","conditions":"Encephalitis, Tick-borne","enrollment":615},{"nctId":"NCT00161967","phase":"PHASE4","title":"TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2005-05","conditions":"Encephalitis, Tick-Borne","enrollment":375},{"nctId":"NCT00161889","phase":"PHASE2","title":"FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years","status":"COMPLETED","sponsor":"Pfizer","startDate":"2002-02","conditions":"Encephalitis, Tick-borne","enrollment":615},{"nctId":"NCT00503529","phase":"PHASE4","title":"TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2007-07","conditions":"Encephalitis, Tick-Borne","enrollment":314},{"nctId":"NCT00461695","phase":"PHASE4","title":"Influence of Persistent CMV-infection on Immune Senescence","status":"COMPLETED","sponsor":"University of Zurich","startDate":"2007-05","conditions":"Immune Senescence","enrollment":183},{"nctId":"NCT00804219","phase":"PHASE4","title":"Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2008-12","conditions":"Tick-borne Encephalitis","enrollment":67},{"nctId":"NCT00890422","phase":"PHASE2","title":"Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine","status":"UNKNOWN","sponsor":"Elisabethinen Hospital","startDate":"2007-03","conditions":"Tick Borne Encephalitis","enrollment":99}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"FSME-IMMUN Vaccine","genericName":"FSME-IMMUN Vaccine","companyName":"Region Örebro County","companyId":"region-rebro-county","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FSME-IMMUN is an inactivated tick-borne encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against TBEV. Used for Prevention of tick-borne encephalitis (TBE) in endemic areas.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}