Phase 4
Completed N=116
Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Vaccine Efficacy
Source: ClinicalTrials.gov NCT02511587 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine — 574.8; 612.0 Geometric mean titers
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine |
574.8; 612.0 | — |
| SECONDARY Cellular Immune Responses - Cytokines |
2376; 2199; 3071; 3387; 81.8; 57.6 | — |
| SECONDARY TBE Titer Profile |
249.9; 208.8; 360.9; 317.2; 574.8; 612.0 | — |
Eligibility Criteria
Inclusion Criteria
- completed primary TBE immunization + at least one booster immunization
- adults of both sexes between 18 and 60 years of age
- willingness to sign written informed consent form
Exclusion Criteria
- age 60 years
- prior TBE infection
- pregnancy and breast feeding
- acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
- concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
- administration of other vaccines 4 weeks before/after day 0
- planned surgery within 2 weeks before/after TBE booster vaccination
- specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
- any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
- history of malignant disease within the last 5 years
- autoimmune diseases
- drug addictions
- plasma donors
- receipt of blood transfusions or immuno globulins within 3 month before study entry
Data sourced from ClinicalTrials.gov (NCT02511587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.