Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule

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 FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.

Official Title
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Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older

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 will be eligible for participation in this study if they: Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age); Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age); Are aged >= 16 years (from the 16th birthday) at screening; Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a 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 will be excluded from participation in this study if they: Have a history of any previous tick-borne encephalitis (TBE) vaccination; Have a history of TBE infection; Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis); Have a history of allergic reactions, in particular to one of the components of the vaccine; Suffer from a disease (e.g. autoimmune disease) 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 level 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 the purpose of this study); Are simultaneously participating in another clinical trial including administration of an investigational product; Have participated in any other clinical study within six weeks prior to study entry; Are pregnant or breastfeeding (if female); Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator. Have received any other vaccination within two weeks prior to study entry.

Ages Eligible for Study
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Minimum Age: 16 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 |
| --- | --- | --- |
| Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined. |  |  |