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

This study has been completed.
Novartis Vaccines
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 3, 2006
Last updated: March 12, 2007
Last verified: March 2007
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

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.

Estimated Enrollment: 179
Study Start Date: February 2006

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00311493

Regensburg, Germany
Sponsors and Collaborators
Novartis Vaccines
Study Director: Drug Information Services Chiron Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00311493     History of Changes
Other Study ID Numbers: V48P2E3  498 
Study First Received: April 3, 2006
Last Updated: March 12, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Infectious Encephalitis
Nervous System Diseases
RNA Virus Infections
Tick-Borne Diseases
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2016