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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00163540 |
The objective of this study is to investigate the immunogenicity and safety of a third vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule 12 ± 2 days apart.
Condition | Intervention | Phase |
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Encephalitis, Tick-Borne |
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Follow-up, Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated Using a Rapid Immunization Schedule (Follow-up to Study 225) |
Ages Eligible for Study: | 17 Years to 66 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects who:
Belgium | |
SGS Biopharma Research Unit Stuivenberg | |
Antwerp, Belgium, 2060 |
Principal Investigator: | Baxter BioScience Investigator, MD | Baxter BioScience |
Study ID Numbers: | 690501 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00163540 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
tick-borne encephalitis |
Virus Diseases Disinfectants Central Nervous System Infections Tick-borne Encephalitis Formaldehyde Central Nervous System Diseases |
Arbovirus Infections Brain Diseases Tick-Borne Diseases Encephalitis Encephalitis, Tick-Borne |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Flavivirus Infections Nervous System Diseases Formaldehyde Central Nervous System Diseases Central Nervous System Viral Diseases Brain Diseases Pharmacologic Actions |
Encephalitis Tick-Borne Diseases Encephalitis, Tick-Borne Virus Diseases Encephalitis, Viral Disinfectants Central Nervous System Infections Therapeutic Uses Arbovirus Infections Encephalitis, Arbovirus |