- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161798
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Augsburg, Germany, 86163
- Neuschwansteinstrasse 5
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Bad Saulgau, Germany, 88348
- Marktplatz 33
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Bietigheim-Bissingen, Germany, 74321
- Hauptstrasse 9
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Calw, Germany, 75365
- Salzgasse 11
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Coburg, Germany, 96450
- Mohrenstrasse 8
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Elzach, Germany, 79215
- Bahnhofstrasse 1
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Ettenheim, Germany, 77955
- Rheinstrasse 13
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Gersfeld, Germany, 36129
- Peter-Seifert Strasse 5
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Heilbronn, Germany, 74072
- Solothurner Strasse 2
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Kehl, Germany, 77694
- Hauptstrasse 240
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Kirchzarten, Germany, 79199
- Schwarzwaldstrasse 20
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Landsberg, Germany, 86899
- Altoettingerstrasse 3
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Mannheim-Secken, Germany, 68239
- Rastatter Strasse 7
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Metzingen, Germany, 72555
- Wilhelmstrasse 25
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Neustadt/Cbg, Germany, 96465
- Heubischer Strasse 39
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Nürnberg, Germany, 90449
- Dohmbuehlerstrasse 8
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Oberkirch, Germany, 77704
- Schwarzwaldstrasse 18
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Offenburg, Germany, 77656
- Asternweg 11a
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Offenburg, Germany, 77654
- Wilhelmstrasse 7
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Rottweil, Germany, 78628
- Bergstrasse 27
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Schrammberg, Germany, 78713
- Berneckstrasse 19
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Tegernsee, Germany, 83681
- Hauptstrasse 11
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Weingarten, Germany, 88250
- Broner Platz 6
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrich Behre, MD, Hauptstrasse 240, 77694 Kehl, Germany
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Tick-Borne Diseases
- Encephalitis
- Encephalitis, Tick-Borne
Other Study ID Numbers
- 205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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