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Trial record 1 of 1 for:    NCT00161824
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Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161824
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Information provided by:

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date May 21, 2015
Study Start Date  ICMJE October 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Condition  ICMJE Encephalitis, Tick-borne
Intervention  ICMJE Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September¬†12,¬†2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00161824
Other Study ID Numbers  ICMJE 208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Pfizer
Verification Date May 2015

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