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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161785 |
The purpose of this study is to assess:
Condition | Intervention | Phase |
---|---|---|
Tick-Borne Encephalitis |
Biological: FSME-IMMUN 0.5ml |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years to 67 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and female subjects will be eligible for participation in this study if:
Exclusion Criteria:
Subjects will be excluded from participation in this study if they:
Subjects will not be eligible for booster vaccination if:
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 have received any vaccination within two weeks prior to the booster vaccination will not be vaccinated until an interval of two weeks has passed.
If subjects have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
Poland | |
Hospital in Debica - Zespo Opieki Zdrowotnej w Debicy | |
Debica, Poland, 33-200 | |
Szpital Jana Pawla II Oddzial Neuroinfekcji | |
Krakow, Poland, 31-202 |
Principal Investigator: | Ryszard Konior, MD | Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland |
Study ID Numbers: | 223 |
Study First Received: | September 8, 2005 |
Last Updated: | October 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00161785 |
Health Authority: | Poland: Ministry of Health |
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 |