Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)

Study Overview
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Brief Summary
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The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.

Official Title
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Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225)

Conditions
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Encephalitis, Tick-borne

Intervention / Treatment
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* Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects who: received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225 understand the nature of the study, agree to its provisions and provide written informed consent are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial) have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) agree to keep a Subject Diary Exclusion Criteria: Subjects who: have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225 have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis) have had an allergic reaction to one of the components of the vaccine since participation in Study 225 suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) 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 doses of other alcoholic beverages) have donated blood or plasma within 30 days of study entry have received a blood transfusion or immunoglobulins within 30 days of study entry are known to be HIV positive (an HIV test is not required specifically for this study) are simultaneously participating in another clinical trial including administration of an investigational product have participated in any other clinical study within 6 weeks prior to study start have participated in another Baxter vaccine study in the past 6 months (with the exception of follow-up studies) For female subjects: pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 17 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

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl|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