Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00311493
Collaborator
Novartis Vaccines (Industry)
179
1
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date
:
Feb 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regensburg | Germany |
Sponsors and Collaborators
- Novartis
- Novartis Vaccines
Investigators
- Study Director: Drug Information Services, Chiron Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00311493
Other Study ID Numbers:
- V48P2E3
- 498
First Posted:
Apr 6, 2006
Last Update Posted:
Mar 13, 2007
Last Verified:
Mar 1, 2007
Keywords provided by ,
,
Additional relevant MeSH terms: