FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).

Official Title
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Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 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: Received two vaccinations during the course of Baxter study 208 Understand the nature of the study, agree to its provisions and give written informed consent For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given Exclusion Criteria: None. Volunteers assessed for eligibility to receive a third vaccination. Eligibility to receive third vaccination: ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208 Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial) Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208 Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208 Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages) Have received banked human blood or immunoglobulins within one month of study entry Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208 Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208 Have received an investigational new drug within 6 weeks prior to study start Have a positive pregnancy test at the first medical examination (for females capable of bearing children) Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 66 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tick-borne encephalitis