Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
Phase 4
Completed
- Conditions
- Encephalitis, Tick-Borne
- Registration Number
- NCT00311441
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Healthy male and female children, 1 to 10 years of age.
Exclusion Criteria
- Subjects with documented evidence of TBE
- Subjects, who have been previously vaccinated against TBE
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
- Secondary Outcome Measures
Name Time Method Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of TBE vaccine-induced immune responses in pediatric populations?
How does the immunogenicity of TBE vaccines compare to standard-of-care vaccines in children with tick-borne encephalitis?
What biomarkers correlate with enhanced TBE vaccine efficacy in healthy pediatric subjects?
What adverse events are associated with TBE vaccines in children and how are they managed clinically?
Are there combination vaccine strategies or competitor vaccines showing improved TBE protection in pediatric trials?