NCT00161824.

Trial name or title	"Single‐Blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years"
Methods	Randomized controlled trial; Phase III study
Participants	Inclusion criteria: healthy adults aged between 16 and 65 years; not pregnant Exclusion criteria: history of tick‐borne encephalitis (TBE) vaccination or TBE infection (screening enzyme‐linked immunosorbent assay (ELISA) > 126 Vienna International Units (VIEU)/mL); allergic reactions; previously receiving of products containing polygeline; antipyretics within 4 hours before first dose of TBE vaccine; chronic, degenerative and/or inflammatory disease of the central nervous system; use of immunosuppressive drugs; problems with drug or alcohol abuse; plasma or blood donation within 1 month of study start; 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 breastfeeding
Interventions	Inactivated TBE vaccines 1. FSME‐IMMUN NEW (5 different lots) 2. Encepur adults (2 different lots) Schedule: administered in 2 doses 21 to 35 days apart
Outcomes	Safety
Starting date	October 2001
Contact information	Principal investigator: Jerzy Romaszko, MD PANTAMED sp. z o o. Olsztyn, Poland, 10‐461
Notes	Location: Poland Sponsor: Baxter Healthcare Corporation