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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161850 |
The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).
Condition | Intervention | Phase |
---|---|---|
Encephalitis, Tick-Borne |
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Dose Comparison, Parallel Assignment |
Official Title: | Follow-Up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years |
Ages Eligible for Study: | 1 Year to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:
Exclusion Criteria:
There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.
Volunteers will be excluded from vaccination and consecutive visits in this study if they:
Austria | |
Grieskirchner Strasse 17 | |
Wels, Austria, A-4600 | |
Germany | |
Hauptstrasse 240 | |
Kehl, Germany, D-77694 | |
Neuschwanstein Strasse 5 | |
Augsburg, Germany, D-86163 | |
Hauptstrasse 11 | |
Tegernsee, Germany, D-83681 | |
Altoettinger Strasse 3 | |
Landsberg, Germany, D-86899 | |
Glogauer Strasse 15 | |
Nuernberg, Germany, D-90473 | |
Wilhelmstrasse 25 | |
Metzingen, Germany, D-72555 | |
Wilhelmstrasse 7 | |
Offenburg, Germany, D-77654 | |
Hauptstrasse 9 | |
Bietigheim-Bissingen, Germany, D-74321 | |
Asternweg 11a | |
Offenburg, Germany, D-77656 | |
Solothumer Strasse 2 | |
Heilbronn, Germany, D-74072 | |
Dohmbuehler Strasse 8 | |
Nuernberg, Germany, D-90449 | |
Rastatter Strasse 7 | |
Mannheim-Secken, Germany, 68239 | |
Salzgasse 11 | |
Calw, Germany, D-75365 | |
Peter-Seifert Strasse 5 | |
Gersfeld, Germany, D-36129 | |
Rheinstrasse 1a | |
Ettenheim, Germany, D-77955 | |
Bergstrasse 27 | |
Rottweil, Germany, D-78628 | |
Schwarzwald Strasse 20 | |
Kirchzarten, Germany, D-79199 | |
Mohrenstrasse 8 | |
Coburg, Germany, D-96450 | |
Broner Platz 6 | |
Weingarten, Germany, D-88250 | |
Marktplatz 33 | |
Bad Saulgau, Germany, D-88348 | |
Berneckstrasse 19 | |
Schramberg, Germany, D-78713 | |
Bahnhofstrasse 1 | |
Elzach, Germany, D-79215 | |
Tuchbergstrasse 2 | |
Oberndorf/Neckar, Germany, D-78727 | |
Ehlerstrasse 17 | |
Friedrichshafen, Germany, D-88046 |
Principal Investigator: | Baxter BioScience Investigator | Baxter Healthcare Corporation |
Study ID Numbers: | 206 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00161850 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Virus Diseases Central Nervous System Infections Central Nervous System Diseases 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 |