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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311493
First Posted: April 6, 2006
Last Update Posted: March 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  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
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311493


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

ClinicalTrials.gov Identifier: NCT00311493     History of Changes
Other Study ID Numbers: V48P2E3
498
First Submitted: April 3, 2006
First Posted: April 6, 2006
Last Update Posted: March 13, 2007
Last Verified: March 2007

Keywords provided by Novartis:
TBE
vaccine
adults

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