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 completion of primary immunization with FSME-IMMUN 0.25 ml (3 vaccinations during the predecessor study 209), as well as the immune response to a booster vaccination with FSME-IMMUN 0.25 ml or FSME-IMMUN 0.5 ml administered 36 months after the third vaccination.

Condition	Intervention	Phase
Encephalitis, Tick-Borne	Vaccine: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)	Phase IV

Further Study Details: 

Expected Total Enrollment:  375

Ages Eligible for Study:  3 Years   -   18 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

Study ID Numbers:  700401
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161967
Health Authority: Austria: Federal Ministry for Health and Women
ClinicalTrials.gov processed this record on 2005-09-13