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
Adult Trials: 18+ Years
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
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| 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 | ||||||||||||||||||||||