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

Last updated on November 9, 2019

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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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 SummaryThe 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 DescriptionNot 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
3800
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2002
Primary Completion DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator:Jerzy Romaszko, MDPANTAMED sp. z o o.
Principal Investigator:Jerzy Brzostek, MDZespol Opieki Zdrowotnej w Debicy
Principal Investigator:Jerzy Dziduch, MDSamodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
Principal Investigator:Krystnyna Jurowska, MDPrzedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Principal Investigator:Marian Patrzalek, MDWojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
Principal Investigator:Krzysztof Sladek, MD"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Principal Investigator:Ryszard Konior, MDSzpital Jana Pawla II Oddzial Neuoinfekcji
PRS AccountPfizer
Verification DateMay 2015

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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