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. 2009 Jan 21;2009(1):CD000977. doi: 10.1002/14651858.CD000977.pub2

NCT00311441.

Trial name or title "A Phase IV, Randomized, Controlled, Single‐Blind, Multi‐Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules"
Methods Randomized controlled trial; Phase IV study
Participants Inclusion criteria: healthy male and female children; 1 to 10 years of age
Exclusion criteria: documented tick‐borne encephalitis (TBE) infection and/or have been previously vaccinated with TBE vaccine
Interventions 2 TBE vaccines administered according 2 different schedules.
Outcomes 1. Immunogenicity measured by neutralization test and enzyme‐linked immunosorbent assay (ELISA) on days 28, 42, 300, and 321
2. Tolerability with respect to local and systemic reactions including fever
Starting date March 2005
Contact information Not provided
Notes Location: Germany
Sponsor: Novartis