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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161967 |
The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination (in Study 209).
Protocol amendment of October 2006: The study has been prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations at approximately 3 years after the third vaccination and therefore did not receive a booster vaccination at this time point. Further follow-up of TBE antibody persistence is now included for these subjects at 46 and 58 months after the third vaccination (in Study 209), as well as a booster vaccination offered at either 48 or 60 months after the third vaccination (in Study 209), depending on individual TBE antibody levels.
Condition | Intervention | Phase |
---|---|---|
Encephalitis, Tick-Borne |
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Open-Label Follow-up Study to Investigate the Seropersistence of TBE Antibodies and the Booster Response to a Tick-Borne Encephalitis Vaccine in Children and Adolescents Aged 3 - 18 Years |
Estimated Enrollment: | 375 |
Study Start Date: | May 2005 |
Study Completion Date: | November 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects will not be eligible for booster vaccination if they:
Subjects who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature >=38.0°C, measured orally) at the scheduled time of vaccination will not be vaccinated until their body temperature returns to normal.
Subjects who received any vaccination within 4 weeks prior to the booster vaccination will not be vaccinated until an interval of four weeks has passed.
If subjects received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
Females of childbearing potential will only be vaccinated if they agree to employ adequate birth control measures from 4 weeks before the booster vaccination until the end of the study.
Austria, Upper Austria | |
Grieskirchner Strasse 17 | |
Wels, Upper Austria, Austria, 4600 | |
Germany | |
Hauptstrasse 240 | |
Kehl, Germany, 77694 | |
Poland | |
Niepubliczny ZOZ | |
Zamosc, Poland, 22-400 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Responsible Party: | Baxter Healthcare Corporation ( Martin Kraft, Clinical Project Manager ) |
Study ID Numbers: | 700401 |
Study First Received: | September 8, 2005 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00161967 |
Health Authority: | Austria: Federal Ministry for Health and Women; Germany: Paul-Ehrlich-Institut; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
tick-borne encephalitis |
Virus Diseases Tick-borne encephalitis Antibodies Central Nervous System Infections Central Nervous System Diseases Arbovirus Infections |
Brain Diseases Tick-Borne Diseases Encephalitis Immunoglobulins Encephalitis, Tick-Borne |
Encephalitis, Viral RNA Virus Infections Flaviviridae Infections Flavivirus Infections |
Nervous System Diseases Central Nervous System Viral Diseases Encephalitis, Arbovirus |