Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

Study Overview
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Brief Summary
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The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.

Official Title
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Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 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: Understanding the nature of the study, agreement to its provisions and written informed consent Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age) Aged >= 16 years (from the 16th birthday) to <= 65 years (to the last day before the 66th birthday) Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial) Negative pregnancy test result at the first medical examination (if female and capable of bearing children) Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) Agreeing to keep a subject diary. Exclusion Criteria: History of any previous TBE vaccination History of TBE infection History of infection with other flaviviruses History of vaccination against yellow fever and/or Japanese B-encephalitis History of allergic reactions, in particular to one of the components of the vaccine Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Donation of blood or plasma within one month of study start Having received a blood transfusion or immunoglobulins within one month of study entry HIV positivity (an HIV test is not required specifically for the purpose of this study Simultaneous participation in another clinical trial including administration of an investigational product Participating in any other clinical study within six weeks prior to study start Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies) Pregnancy or lactation (if female) Having received any other vaccination within two weeks prior to study entry

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

Primary Purpose: Prevention
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