NCT00161785.

Trial name or title	"Investigation of the Seropersistence of TBE Antibodies and the Booster Response to FSME‐IMMUN 0.5 ml in Adults Aged 18 ‐ 67 Years"
Methods	Randomized controlled trial; Phase IV study
Participants	Inclusion criteria: age 18 to 67 years; received the third vaccination with FSME‐IMMUN during the course of Baxter study 213 and had blood samples collected before it showing an enzyme‐linked immunosorbent assay (ELISA) concentration > 126 Vienna International Units (VIEU)/mL and/or neutralization test (NT) titre ≥ 1:10 Exclusion criteria: receiving of any tick‐borne encephalitis (TBE) vaccination after third vaccination with FSME‐IMMUN; received yellow fever and/or Japanese encephalitis vaccine; human immunodeficiency virus (HIV)‐positive; drug or alcohol abuse; blood transfusion; participation in other Baxter vaccine studies within the last 6 months
Interventions	Inactivated TBE vaccine "FSME‐IMMUN" (0.5 mL)
Outcomes	1. TBE antibody persistence 2 and 3 years after the third TBE vaccination by means of ELISA and NT 2. TBE antibody response to a booster vaccination, by means of ELISA and NT
Starting date	June 2004
Contact information	Principal investigator: Ryszard Konior, MD Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland
Notes	Locations: Hospital in Debica ‐ Zespo Opieki Zdrowotnej w Debicy, Debica, Poland, 33‐200; Szpital Jana Pawla II Oddzial Neuroinfekcji, Krakow, Poland Sponsor: Baxter Healthcare Corporation