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

Last updated on May 12, 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
16-66 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

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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FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
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
The 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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
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Not Provided

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:

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)
Sexes Eligible for Study: All
16 Years to 66 Years   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00161876
213
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: Krystyna 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 Szpital Jana Pawla II Oddzial Neuoinfekcji
Principal Investigator: Grazyna Zawada-Skrobisz, MD Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow
Pfizer
May 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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