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Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00311493
First received: April 3, 2006
Last updated: March 12, 2007
Last verified: March 2007

April 3, 2006
March 12, 2007
February 2006
Not Provided
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.
Not Provided
Complete list of historical versions of study NCT00311493 on ClinicalTrials.gov Archive Site
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.
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Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
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

The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
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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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00311493
V48P2E3, 498
Not Provided
Not Provided
Novartis
Novartis Vaccines
Study Director: Drug Information Services Chiron Corporation
Novartis
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP