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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | Biological |
Inclusion Criteria:
Exclusion Criteria:
Volunteers assessed for eligibility to receive a third vaccination.
Eligibility to receive third vaccination:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zespol Opieki Zdrowotnej w Debicy | Dębica | 33-200 | Poland | |||
| Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A |
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| ID | Term |
|---|---|
| D004675 | Encephalitis, Tick-Borne |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Kielce |
| 25-381 |
| Poland |
| "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego | Krakow | 30-018 | Poland |
| Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta" | Krakow | 30-969 | Poland |
| Szpital Jana Pawla II Oddzial Neuroinfekcji | Krakow | 31-202 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny | Lubartów | 21-100 | Poland |
| PANTAMED sp. z o.o. | Olsztyn | 10-461 | Poland |
| Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika | Tarnów | 33-100 | Poland |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D017282 | Tick-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |