Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
This study has been completed.
Information provided by:
First received: April 3, 2006
Last updated: March 14, 2008
Last verified: March 2008
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
Biological: Tick-Borne Encephalitis vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official 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.|
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Secondary Outcome Measures:
- Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
|Study Start Date:||March 2005|
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