Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.

Official Title
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Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.

Conditions
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Encephalitis, Tick-borne

Intervention / Treatment
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* Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female volunteers were eligible for participation in this study if they: Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old Were clinically healthy Had a negative pregnancy test at the first medical examination, if female and capable of bearing children Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children Provided written informed consent For volunteers under 18 years of age - written informed consent of the parents / guardian was available Agreed to keep a volunteer diary Exclusion Criteria: History of any previous TBE vaccination History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml) History of allergic reactions, in particular to one of the components of the vaccine Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR) Received antipyretics within 4 hours prior to the first TBE vaccination Suffer from a disease that cannot be effectively treated or stabilized Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics) Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Had donated blood or plasma within one month of the study start Had received banked blood or immunoglobulins within one month of study entry Known to be HIV positive (a special HIV test was not required for the purpose of the study) Suffering from a febrile illness at study entry History of vaccination against yellow fever and / or Japanese B encephalitis Participating simultaneously in another clinical trial If female: pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |