NCT00161798.

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 6 to 16 Years"
Methods	Randomized controlled trial; Phase II study
Participants	Inclusion criteria: healthy children aged between 6 and 15 years Exclusion criteria: previous tick‐borne encephalitis (TBE) vaccination or infection (screening enzyme‐linked immunosorbent assay (ELISA) > 126 Vienna International Units (VIEU)/mL and/or neutralization test > 1:10); allergic reactions; antipyretics within 4 hours before TBE vaccination; chronic, degenerative and/or inflammatory disease of the central nervous system; human immunodeficiency virus (HIV) positive; febrile illness at study entry; history of yellow fever and/or Japanese encephalitis vaccination; participation in another trial; pregnancy or breast feeding
Interventions	Inactivated TBE vaccine FSME‐IMMUN NEW administered in 3 different dosages
Outcomes	1. Safety 2. Immunogenicity
Starting date	September 2001
Contact information	Principal investigator: Ulrich Behre, MD, Hauptstrasse 240, 77694 Kehl, Germany
Notes	Location: Germany Sponsor: Baxter Healthcare Corporation