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FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

Last updated on November 30, 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
16-66 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Received two vaccinations during the course of Baxter study 208

- Understand the nature of the study, agree to its provisions and give written informed
consent

- For volunteers under 18 years of age - written informed consent of the parents/legal
guardian is given

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

- None.

Volunteers assessed for eligibility to receive a third vaccination.

Eligibility to receive third vaccination:

- ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208

- Not clinically healthy, (i.e. the physician would have reservations vaccinating with
FSME-IMMUN NEW outside the scope of a clinical trial)

- Have already been administered a third TBE vaccination elsewhere since receiving the
two vaccinations in Baxter study 208

- Have had an allergic reaction to one of the components of the vaccine since the last
vaccination in Baxter study 208

- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence
immunological functions

- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent dose of other alcoholic beverages)

- Have received banked human blood or immunoglobulins within one month of study entry

- Are known to have become infected with HIV (a special HIV test is not required for the
purpose of the study) since the last visit of study 208

- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the
last visit in study 208

- Have received an investigational new drug within 6 weeks prior to study start

- Have a positive pregnancy test at the first medical examination (for females capable
of bearing children)

- Do not agree to employ adequate birth control measures for the duration of the study
(for females capable of bearing children)

NCT00161876
Pfizer
Completed
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years

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Descriptive Information
Brief Title  ICMJE FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
Official Title  ICMJE Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 Years
Brief SummaryThe aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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)
3973
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2002
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Received two vaccinations during the course of Baxter study 208
  • Understand the nature of the study, agree to its provisions and give written informed consent
  • For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given

Exclusion Criteria:

  • None.

Volunteers assessed for eligibility to receive a third vaccination.

Eligibility to receive third vaccination:

  • ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
  • Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
  • Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages)
  • Have received banked human blood or immunoglobulins within one month of study entry
  • Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
  • Have received an investigational new drug within 6 weeks prior to study start
  • Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
  • Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years to 66 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 NCT00161876
Other Study ID Numbers  ICMJE 213
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:Krystyna 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 KoniorSzpital Jana Pawla II Oddzial Neuoinfekcji
Principal Investigator:Grazyna Zawada-Skrobisz, MDOddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow
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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