FSME IMMUN NEW Follow-Up to Study 208 in Volunteers Aged 16 to 66 Years
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161876
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006
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Purpose
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 3 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
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 |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Eligibility
Ages Eligible for Study: | 16 Years to 66 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Received two vaccinations during the course of Baxter study 208
- Understand the nature of the study, agree to its provisions and give written informed consent
- For volunteers under 18 years of age – written informed consent of the parents/legal guardian is given
Exclusion Criteria:
- None.
Volunteers assessed for eligibility to receive a third vaccination.
Eligibility to receive third vaccination:
- ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
- Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages)
- Have received banked human blood or immunoglobulins within one month of study entry
- Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
- Have received an investigational new drug within 6 weeks prior to study start
- Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
- Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161876
Locations
Poland | |
Zespol Opieki Zdrowotnej w Debicy | |
Debica, Poland, 33-200 | |
Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A | |
Kielce, Poland, 25-381 | |
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta" | |
Krakow, Poland, 30-969 | |
Szpital Jana Pawla II Oddzial Neuroinfekcji | |
Krakow, Poland, 31-202 | |
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego | |
Krakow, Poland, 30-018 | |
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny | |
Lubartow, Poland, 21-100 | |
PANTAMED sp. z o.o. | |
Olsztyn, Poland, 10-461 | |
Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika | |
Tarnow, Poland, 33-100 |
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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 |
More Information
No publications provided
Keywords provided by Baxter Healthcare Corporation:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00161876 History of Changes |
Other Study ID Numbers: | 213 |
Study First Received: | September 8, 2005 |
Last Updated: | June 12, 2006 |
Health Authority: | Poland: Ministry of Health |
Keywords provided by Baxter Healthcare Corporation:
tick-borne encephalitis |
Additional relevant MeSH terms:
Encephalitis Encephalitis, Tick-Borne Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections |
Encephalitis, Arbovirus Arbovirus Infections Tick-Borne Diseases Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on October 16, 2012