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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161798 |
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.
Condition | Intervention | Phase |
---|---|---|
Tick-Borne Encephalitis |
Biological: Tick-borne encephalitis vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment |
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. |
Ages Eligible for Study: | 6 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
Exclusion Criteria:
Children will be excluded from participation in this study if they:
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.
Germany | |
Hauptstraße 240 | |
Kehl, Germany, 77694 | |
Neuschwansteinstrasse 5 | |
Augsburg, Germany, 86163 | |
Hauptstrasse 11 | |
Tegernsee, Germany, 83681 | |
Altoettingerstrasse 3 | |
Landsberg, Germany, 86899 | |
Wilhelmstrasse 25 | |
Metzingen, Germany, 72555 | |
Schwarzwaldstrasse 18 | |
Oberkirch, Germany, 77704 | |
Wilhelmstrasse 7 | |
Offenburg, Germany, 77654 | |
Heubischer Strasse 39 | |
Neustadt/Cbg, Germany, 96465 | |
Hauptstrasse 9 | |
Bietigheim-Bissingen, Germany, 74321 | |
Asternweg 11a | |
Offenburg, Germany, 77656 | |
Solothurner Strasse 2 | |
Heilbronn, Germany, 74072 | |
Rastatter Strasse 7 | |
Mannheim-Secken, Germany, 68239 | |
Salzgasse 11 | |
Calw, Germany, 75365 | |
Peter-Seifert Strasse 5 | |
Gersfeld, Germany, 36129 | |
Rheinstrasse 13 | |
Ettenheim, Germany, 77955 | |
Bergstrasse 27 | |
Rottweil, Germany, 78628 | |
Schwarzwaldstrasse 20 | |
Kirchzarten, Germany, 79199 | |
Mohrenstrasse 8 | |
Coburg, Germany, 96450 | |
Broner Platz 6 | |
Weingarten, Germany, 88250 | |
Marktplatz 33 | |
Bad Saulgau, Germany, 88348 | |
Berneckstrasse 19 | |
Schrammberg, Germany, 78713 | |
Bahnhofstrasse 1 | |
Elzach, Germany, 79215 | |
Dohmbuehlerstrasse 8 | |
Nürnberg, Germany, 90449 |
Principal Investigator: | Ulrich Behre, MD | Hauptstrasse 240, 77694 Kehl, Germany |
Study ID Numbers: | 205 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00161798 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Virus Diseases Tick-borne encephalitis Signs and Symptoms Central Nervous System Infections Central Nervous System Diseases Healthy |
Arbovirus Infections Brain Diseases Tick-Borne Diseases Encephalitis Encephalitis, Tick-Borne |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |