Phase 4 N=116 Randomized Prevention

Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

Vaccine Efficacy

Bottom Line

View on ClinicalTrials.gov: NCT02511587 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine — 574.8; 612.0 Geometric mean titers

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: FSME-Immune vaccination (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Medical University of Vienna
Primary completion: Jun 2015

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	—

Summary

FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

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

View full record on ClinicalTrials.gov →

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.