drugset / Trial / NCT00161863
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.
Timeline
- Start
- 2002-09
- Primary completion
- —
- Completion
- 2003-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FSME IMMUN NEW | Vaccine | 0.25 ml | — |