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
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311493

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

No publications provided

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:
TBE
vaccine
adults

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Tick-Borne
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 26, 2014