Status:
COMPLETED
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-borne
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief Summary
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 consecuti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2002
Estimated Enrollment :
3800 Patients enrolled
Trial Details
Trial ID
NCT00161824
Start Date
October 1 2001
End Date
January 1 2002
Last Update
May 21 2015
Active Locations (7)
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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