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

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161876
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006
  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:

Estimated Enrollment: 3973
Study Start Date: May 2002
Estimated Study Completion Date: August 2002
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Krakow, Poland, 30-018
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Krakow, Poland, 30-969
Szpital Jana Pawla II Oddzial Neuroinfekcji
Krakow, Poland, 31-202
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

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, Tick-Borne
Encephalitis
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Tick-Borne Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014