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
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
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 April 17, 2014