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 |