Trial record 16 of 32 for:    "Encephalitis, Tick-Borne"

Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161824
First received: September 8, 2005
Last updated: October 18, 2006
Last verified: October 2006
  Purpose

The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Single-Blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 3800
Study Start Date: October 2001
Estimated Study Completion Date: January 2002
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Male and female volunteers were eligible for participation in this study if they:

  • Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
  • Were clinically healthy
  • Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
  • Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
  • Provided written informed consent
  • For volunteers under 18 years of age – written informed consent of the parents / guardian was available
  • Agreed to keep a volunteer diary

Exclusion Criteria:

  • History of any previous TBE vaccination
  • History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)
  • History of allergic reactions, in particular to one of the components of the vaccine
  • Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
  • Received antipyretics within 4 hours prior to the first TBE vaccination
  • Suffer from a disease that cannot be effectively treated or stabilized
  • Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions
  • Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system
  • Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)
  • Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
  • Had donated blood or plasma within one month of the study start
  • Had received banked blood or immunoglobulins within one month of study entry
  • Known to be HIV positive (a special HIV test was not required for the purpose of the study)
  • Suffering from a febrile illness at study entry
  • History of vaccination against yellow fever and / or Japanese B encephalitis
  • Participating simultaneously in another clinical trial
  • If female: pregnant or breast feeding
  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: NCT00161824

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
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: Krystnyna 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, MD Szpital Jana Pawla II Oddzial Neuoinfekcji
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161824     History of Changes
Other Study ID Numbers: 208
Study First Received: September 8, 2005
Last Updated: October 18, 2006
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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 August 28, 2014