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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161889 |
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 volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 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 6 to 16 Years |
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
All volunteers who participated in Baxter study 205 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:
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 | |
Wilhelmstrasse 25 | |
Metzingen, Germany, D-72555 | |
Wilhelmstrasse 7 | |
Offenburg, Germany, D-77654 | |
Hauptstrasse 9 | |
Bietigheim-Bissingen, Germany, D-74321 | |
Solothumer Strasse 2 | |
Heilbronn, Germany, D-74072 | |
Dohmbuehler Strasse 8 | |
Nuernberg, Germany, D-90449 | |
Rastatter Strasse 7 | |
Mannheim-Secken, Germany, 68239 | |
Peter-Seifert Strasse 5 | |
Gersfeld, Germany, D-36129 | |
Rheinstrasse 1a | |
Ettenheim, Germany, D-77955 | |
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 | |
Salzgasse 11 | |
Calw, Germany, D-75365 |
Principal Investigator: | Baxter BioScience Investigator | Baxter Healthcare Corporation |
Study ID Numbers: | 207 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00161889 |
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 |