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Trial record 12 of 36 for:    "Encephalitis, Tick-Borne"

FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

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ClinicalTrials.gov Identifier: NCT00161876
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

September 8, 2005
September 13, 2005
May 21, 2015
May 2002
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Complete list of historical versions of study NCT00161876 on ClinicalTrials.gov Archive Site
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FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
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
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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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Encephalitis, Tick-borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3973
Same as current
August 2002
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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:

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)
Sexes Eligible for Study: All
16 Years to 66 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00161876
213
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Pfizer
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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
Pfizer
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP