Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

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).

Timeline

Start

2009-02-06

Primary completion

2010-05-20

Completion

2010-05-20

Outcome

Met primary endpoint

registry analysis (unspecified test); FSME-IMMUN vs Encepur; p <0.001; Stratified score test NCT00840801 ↗

Drugs

Indications