Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
NCT00161824
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Fukuoka,, Fukuoka
- Ebetsu Shi, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaido
- Kofu-city, Yamanashi
- Augsburg,
- Bad Saulgau,
- Bietigheim-Bissingen,
- Calw,
- Coburg,
- Elzach,
- Ettenheim,
- Gersfeld,
- Heilbronn,
- Kehl,
- Kirchzarten,
- Landsberg,
- Mannheim-Secken,
- Metzingen,
- Nuernberg,
- Offenburg,
- Schramberg,
- Tegernsee,
- Weingarten,
- Eferding, Upper Austria
- Wels, Upper Austria
- Havlickuv Brod,
- Hradec Králové,
- Pardubice-Polabiny,
- Pardubice,
- Pardubice,
- Pardubice,
- Wels,
- Bad Saulgau,
- Heilbronn,
- Kehl,
- Kielce,
- Krakow,
- Lubartow,
- Olsztyn,
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 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 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years. | |||||||||||||||||||||
Detailed Description | Not 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 | 3800 | |||||||||||||||||||||
Original Enrollment ICMJE | Same as current | |||||||||||||||||||||
Study Completion Date ICMJE | January 2002 | |||||||||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Male and female volunteers were eligible for participation in this study if they:
Exclusion Criteria:
| |||||||||||||||||||||
Sex/Gender ICMJE |
| |||||||||||||||||||||
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 Committee | Not Provided | |||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
Responsible Party | Not Provided | |||||||||||||||||||||
Study Sponsor ICMJE | Pfizer | |||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||
Investigators ICMJE |
| |||||||||||||||||||||
PRS Account | Pfizer | |||||||||||||||||||||
Verification Date | May 2015 | |||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |