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FSME-IMMUN Vaccine
FSME-IMMUN is an inactivated tick-borne encephalitis virus vaccine that stimulates the immune system to produce antibodies and cellular immunity against TBEV.
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.
At a glance
| Generic name | FSME-IMMUN Vaccine |
|---|---|
| Sponsor | Region Örebro County |
| Drug class | Inactivated viral vaccine |
| Target | Tick-borne encephalitis virus (TBEV) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Prevention of tick-borne encephalitis (TBE) in endemic areas
Common side effects
- Injection site pain, redness, or swelling
- Headache
- Myalgia
- Fever
- Fatigue
Key clinical trials
- Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy
- Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children (PHASE3)
- Primary TBE Vaccination for the Elderly (PHASE4)
- Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients (PHASE2)
- TBE (Tick-borne Encephalitis) Vaccination in Allergic Patients (PHASE4)
- Application of a TBE-Vaccine in Obese Persons (PHASE4)
- Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) (PHASE2)
- Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years. (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FSME-IMMUN Vaccine CI brief — competitive landscape report
- FSME-IMMUN Vaccine updates RSS · CI watch RSS
- Region Örebro County portfolio CI