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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00503529 |
The purpose of this study is to assess:
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, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223) |
Estimated Enrollment: | 300 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
Subjects will not be eligible for booster vaccination if they:
Poland | |
Szpital Jana Pawla II (The John Paul II Hospital) Oddzial Neuroinfekcji | |
Krakow, Poland, 31-202 | |
Hospital in Debica - Zespol Opieki Zdrowotnej w Debicy | |
Debica, Poland, 33-200 |
Principal Investigator: | Ryszard Konior, MD | The John Paul II Hospital, Krakow, Poland |
Responsible Party: | Baxter Healthcare Corporation ( Katrin Koelling-Schlebusch, Clinical Project Manager ) |
Study ID Numbers: | 690701, EUDRACT # 2007-000440-27 |
Study First Received: | July 17, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00503529 History of Changes |
Health Authority: | Poland: Ministry of Health |
Virus Diseases Antibodies Central Nervous System Infections Tick-borne Encephalitis Central Nervous System Diseases Arbovirus Infections |
Brain Diseases Tick-Borne Diseases Encephalitis Immunoglobulins Encephalitis, Tick-Borne |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Nervous System Diseases Central Nervous System Diseases Central Nervous System Viral Diseases Brain Diseases Encephalitis |
Tick-Borne Diseases Encephalitis, Tick-Borne Virus Diseases Encephalitis, Viral Central Nervous System Infections Arbovirus Infections Encephalitis, Arbovirus |