At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE
In Brief
A Phase 3 clinical trial evaluating Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) for Encephalitis, Tick-Borne. Completed, enrolled 302 participants across 8 sites in 2 countries.
Detailed Summary
The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).
Study Details
Timeline
Interventions
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.