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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161954 |
The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.
Condition | Intervention | Phase |
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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 |
Official Title: | Open Phase IV Clinical Study to Evaluate the Immunogenicity and Safety of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
SGS Biopharma Research Unit Stuivenberg | |
Antwerp, Belgium, 2060 |
Principal Investigator: | Baxter BioScience Investigator | Baxter BioScience |
Study ID Numbers: | 225 |
Study First Received: | September 8, 2005 |
Last Updated: | October 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00161954 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Tick-Borne Encephalitis |
Virus Diseases Tick-borne encephalitis Central Nervous System Infections Central Nervous System Diseases Healthy |
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 |