Back to resultsEvaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
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, vaccine, adults
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination Exclusion Criteria: Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Sites / Locations
Outcomes
Primary Outcome Measures
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Secondary Outcome Measures
Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.
Full Information
NCT ID
NCT00311493
First Posted
April 3, 2006
Last Updated
March 12, 2007
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00311493
Brief Title
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
Official Title
A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2006 (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 it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-Borne
Keywords
TBE, vaccine, adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Tick-Borne Encephalitis vaccine
Primary Outcome Measure Information:
Title
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Secondary Outcome Measure Information:
Title
Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination
Exclusion Criteria:
Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drug Information Services
Organizational Affiliation
Chiron Corporation
Official's Role
Study Director
Facility Information:
City
Regensburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
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