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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161876 |
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
Condition | Intervention | Phase |
---|---|---|
Encephalitis, Tick-Borne |
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Open-Label, Multicenter, Follow-Up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 Years |
Ages Eligible for Study: | 16 Years to 66 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Volunteers assessed for eligibility to receive a third vaccination.
Eligibility to receive third vaccination:
Poland | |
PANTAMED sp. z o.o. | |
Olsztyn, Poland, 10-461 | |
Zespol Opieki Zdrowotnej w Debicy | |
Debica, Poland, 33-200 | |
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny | |
Lubartow, Poland, 21-100 | |
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta" | |
Krakow, Poland, 30-969 | |
Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika | |
Tarnow, Poland, 33-100 | |
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego | |
Krakow, Poland, 30-018 | |
Szpital Jana Pawla II Oddzial Neuroinfekcji | |
Krakow, Poland, 31-202 | |
Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A | |
Kielce, Poland, 25-381 |
Principal Investigator: | Jerzy Romaszko, MD | PANTAMED sp. z o o. |
Principal Investigator: | Jerzy Brzostek, MD | Zespol Opieki Zdrowotnej w Debicy |
Principal Investigator: | Jerzy Dziduch, MD | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny |
Principal Investigator: | Krystyna Jurowska, MD | Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta" |
Principal Investigator: | Marian Patrzalek, MD | Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A |
Principal Investigator: | Krzysztof Sladek, MD | "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego |
Principal Investigator: | Ryszard Konior | Szpital Jana Pawla II Oddzial Neuoinfekcji |
Principal Investigator: | Grazyna Zawada-Skrobisz, MD | Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow |
Study ID Numbers: | 213 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00161876 |
Health Authority: | Poland: Ministry of Health |
tick-borne encephalitis |
Virus Diseases Tick-borne encephalitis Central Nervous System Infections Central Nervous System Diseases 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 |