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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-06-30

Brief Summary

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

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Detailed Description

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Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.

Conditions

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Vaccine Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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intra muscular application

intra muscular application of FSME-Immune vaccination

Group Type ACTIVE_COMPARATOR

FSME-Immune vaccination

Intervention Type BIOLOGICAL

booster vaccination with FSME-Immune

subcutaneous application

subcutaneous application of FSME-Immune vaccination

Group Type EXPERIMENTAL

FSME-Immune vaccination

Intervention Type BIOLOGICAL

booster vaccination with FSME-Immune

Interventions

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FSME-Immune vaccination

booster vaccination with FSME-Immune

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 \< 18 and \> 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes