TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223)
NCT00503529
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
- Subjects who participated in Study 223 will be eligible for participation in this study if:
- they understand the nature of the study, agree to its provisions and provide written informed consent
- they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223
- blood was drawn after their first booster vaccination in Study 223.
Subjects will be excluded from participation in this study if they:
- received any TBE vaccination since their first booster vaccination with FSME-IMMUN
0.5ml
- have a history of infection with or vaccination against other flaviviruses (e.g.
dengue fever, yellow fever, Japanese B-encephalitis) since their first booster
vaccination with FSME-IMMUN 0.5ml
- are known to be HIV positive (a special HIV test is not required for the purpose of
the study) since their first booster vaccination with FSME-IMMUN 0.5ml
- have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week
or equivalent level of other alcoholic beverages).
Subjects will not be eligible for booster vaccination if they:
- are not clinically healthy, (i. e. the physician would have reservations vaccinating
with FSME-IMMUN 0.5ml outside the scope of a clinical trial)
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
(e.g. systemic corticosteroids) that can be expected to influence immunological
functions
- are females of childbearing potential and are pregnant or breastfeeding before the
booster vaccination (positive pregnancy test result at the medical examination before
the booster vaccination)
- have shown an allergic reaction to one of the components of the vaccine since their
first booster vaccination in Study 223
- are simultaneously participating in another clinical trial including administration of
an investigational product within six weeks prior to the booster vaccination until the
end of the study
- do not agree to keep a Subject Diary.
- Subjects who meet the eligibility criteria, but have a febrile illness (body
temperature >= 38.0°C, measured orally) at the scheduled time of vaccination, will not
be vaccinated until their body temperature returns to normal.
- Subjects who have been administered any vaccination within 2 weeks prior to the
booster vaccination will not be vaccinated until an interval of two weeks has passed.
- If subjects have received antipyretics within 4 hours prior to the scheduled time of
vaccination, the vaccination should be performed at a later time.
- If a subject had a tick-bite within 4 weeks of the scheduled booster vaccination, the
vaccination shall be delayed such that an interval of 4 weeks has passed since the
tick-bite in order to avoid any interference with diagnostic assays in the event of a
TBE infection.
- If a subject has donated blood or plasma or has received a blood transfusion or
immunoglobulins within 4 weeks of the scheduled booster vaccination, the vaccination
shall be delayed until an interval of 4 weeks has passed.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) | |||
Official Title ICMJE | Open-label Phase IV Study to Investigate the Seropersistence of Tick Borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to a Second Booster Vaccination With FSME-IMMUN 0.5ml in Adults (Follow Up to Study 223) | |||
Brief Summary | The purpose of this study is to assess:
| |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Encephalitis, Tick-Borne | |||
Intervention ICMJE | Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Vaccination by intramuscular injection into the right or left upper arm (musculus deltoideus) Other Name: FSME-IMMUN 0.5 ml | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Konior R, Brzostek J, Poellabauer EM, Jiang Q, Harper L, Erber W. Seropersistence of TBE virus antibodies 10 years after first booster vaccination and response to a second booster vaccination with FSME-IMMUN 0.5mL in adults. Vaccine. 2017 Jun 16;35(28):3607-3613. doi: 10.1016/j.vaccine.2017.03.059. Epub 2017 May 22. | |||
* 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 | |||
Actual Enrollment ICMJE | 314 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | September 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Subjects will be excluded from participation in this study if they:
Subjects will not be eligible for booster vaccination if they:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (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 | NCT00503529 | |||
Other Study ID Numbers ICMJE | 690701 EUDRACT # 2007-000440-27 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
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 |