NCT00161772.

Trial name or title	"Double‐Blind, Randomized, Multicenter Dose‐Finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years"
Methods	Randomized controlled trial; Phase II study
Participants	Inclusion criteria: healthy children aged between 1 and 5 years Exclusion criteria: history of previous tick‐borne encephalitis (TBE) vaccination or TBE infection; allergic reactions; received antipyretics before immunization; chronic, degenerative and/or inflammatory disease of the central nervous system; human immunodeficiency virus (HIV) seropositivity; febrile illness at study entry; history of yellow fever and/or Japanese encephalitis
Interventions	Inactivated TBE vaccine administered in 3 different dosages
Outcomes	1. Safety 2. Immunogenicity
Starting date	March 2002
Contact information	Principal investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
Notes	Sponsor: Baxter Healthcare Corporation