Back to resultsStudy of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
Primary Purpose
Encephalitis, Tick-Borne
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Tick-Borne Encephalitis vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Encephalitis, Tick-Borne focused on measuring TBE, children, vaccine
Eligibility Criteria
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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00311441
First Posted
April 3, 2006
Last Updated
March 14, 2008
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00311441
Brief Title
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-Borne
Keywords
TBE, children, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Tick-Borne Encephalitis vaccine
Primary Outcome Measure Information:
Title
Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Secondary Outcome Measure Information:
Title
Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Director
Facility Information:
City
Weilheim
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
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