The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

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

Further Study Details: 

Ages Eligible for Study:  6 Months   -   47 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Male and female children aged between 6 and 47 months
• No history of any previous TBE vaccination
• Clinically healthy
• Informed consent provided by the parents

Exclusion Criteria:

• History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
• Suffering from a disease that cannot be effectively treated or stabilised
• Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
• Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
• HIV-positivity (no special HIV test required for the purpose of the study)
• Suffering from a febrile disease
• History of vaccination against yellow fever and/or Japanese encephalitis
• Participation in another clinical trial

Austria
      University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine, Vienna,  1095,  Austria
Austria, Kärnten (Carinthia)
      Villach,  Kärnten (Carinthia),  9500,  Austria

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

Study ID Numbers:  146A
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161746
Health Authority: Austria: Federal Ministry for Health and Women
ClinicalTrials.gov processed this record on 2005-09-13