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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Zespol Opieki Zdrowotnej w Debicy
Debica, , 33-200 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00161824
Pfizer
Completed
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR

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Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Encephalitis, Tick-borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3800
January 2002
Not Provided

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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00161824
208
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
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
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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