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 subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 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:  1 Year   -   6 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

All volunteers who participated in Baxter study 199 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 199
• Written informed consent from the legal guardian is available.

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 199
• Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
• 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 199
• Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
• Had received an investigational new drug within 6 weeks prior to study start

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

Study ID Numbers:  206
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161850
Health Authority: Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13