Status:
COMPLETED
TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209)
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-Borne
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the seropersistence of TBE antibodies in children and adolescents aged 1 to 15 years at the time of their first vaccination, 24 months and 34 months after comple...
Eligibility Criteria
Inclusion
- Participated in Baxter study 209 and:
- They and/or their parents / legal guardians understand the nature of the study and agree to its provisions
- Written informed consent is available from the parents / legal guardians according to national law
- Written informed assent is available from the child/adolescent according to age and capacity of understanding
- They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209
- Blood was drawn after their third vaccination during the course of Baxter study 209
- They showed an ELISA concentration \> 126 VIE U/ml and / or a NT titer \>=10 after the third vaccination in Baxter study 209
- They or their parents / legal guardians agree to keep a Subject Diary
Exclusion
- Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml
- Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml
- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml
- Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable)
- Have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages)
- Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
- Subjects will not be eligible for booster vaccination if they:
- Do not meet the inclusion / exclusion criteria
- Are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine 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
- Have shown an allergic reaction to one of the components of the vaccine since their third vaccination in Baxter study 209
- Have donated blood or plasma within 30 days of the booster vaccination if female of childbearing potential - are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination)
- 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
- Subjects who meet the inclusion/exclusion 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 received any vaccination within 4 weeks prior to the booster vaccination will not be vaccinated until an interval of four weeks has passed.
- If subjects received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time.
- Females of childbearing potential will only be vaccinated if they agree to employ adequate birth control measures from 4 weeks before the booster vaccination until the end of the study.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00161967
Start Date
May 1 2005
End Date
November 1 2008
Last Update
May 21 2015
Active Locations (3)
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1
Grieskirchner Strasse 17
Wels, Upper Austria, Austria, 4600
2
Hauptstrasse 240
Kehl, Germany, 77694
3
Niepubliczny ZOZ
Zamość, Poland, 22-400