Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.

Official Title
-----------------
Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

Conditions
-----------------
Tick-borne Encephalitis

Intervention / Treatment
-----------------
* Biological: Tick-borne encephalitis vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children will be eligible for participation in this study if: they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday); they are clinically healthy; their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent; their legal representative agrees to keep a Volunteer Diary. For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start: negative pregnancy test at study start; they agree to employ adequate birth control measures for the duration of the study. Exclusion Criteria: Children will be excluded from participation in this study if they: have a history of any previous TBE vaccination; have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10); have a history of allergic reactions, in particular to one of the components of the vaccine; have received antipyretics within 4 hours prior to the first TBE vaccination; suffer from a disease that cannot be effectively treated or stabilized; suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions; suffer from chronic, degenerative and / or inflammatory disease of the central nervous system; are known to be HIV positive (a special HIV test is not required for the purpose of the study); suffer from a febrile illness at study entry; have a history of vaccination against yellow fever and / or Japanese B-encephalitis; are participating simultaneously in another clinical trial. if female, are pregnant or breast feeding Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-borne encephalitis vaccine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

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