{"id":"fsme-immune-vaccination","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain, redness, or swelling"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Myalgia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Low-grade fever"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The vaccine contains inactivated TBEV antigen that triggers both humoral (antibody) and cell-mediated immune responses. This priming of the adaptive immune system enables rapid recognition and neutralization of the virus upon natural exposure, preventing infection or reducing disease severity.","oneSentence":"FSME-Immune 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":"2026-03-28T00:39:35.973Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of tick-borne encephalitis (TBEV infection)"}]},"trialDetails":[{"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":"NCT02511587","phase":"PHASE4","title":"Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2012-10","conditions":"Vaccine Efficacy","enrollment":116},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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-Immune vaccination","genericName":"FSME-Immune vaccination","companyName":"Medical University of Vienna","companyId":"medical-university-of-vienna","modality":"Biologic","firstApprovalDate":"","aiSummary":"FSME-Immune 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 (TBEV infection).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}