Status:
COMPLETED
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-borne
Eligibility:
All Genders
16-66 years
Phase:
PHASE3
Brief Summary
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 EN...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
3973 Patients enrolled
Trial Details
Trial ID
NCT00161876
Start Date
May 1 2002
End Date
August 1 2002
Last Update
May 21 2015
Active Locations (8)
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1
Zespol Opieki Zdrowotnej w Debicy
Dębica, Poland, 33-200
2
Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
Kielce, Poland, 25-381
3
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Krakow, Poland, 30-018
4
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Krakow, Poland, 30-969