The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).

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

Further Study Details: 

Expected Total Enrollment:  615

Ages Eligible for Study:  6 Years   -   16 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion criteria:

All volunteers who participated in Baxter study 205 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

• They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 205
• They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

• Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
• Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 205
• Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
• Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
• Have received banked human blood or immunoglobulins within one month of study entry
• Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
• Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
• Had received an investigational new drug within 6 weeks prior to study start
• If female and capable of bearing children – have a positive pregnancy test at the first medical examination

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

Study ID Numbers:  207
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161889
Health Authority: Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13