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

March 12, 2007 updated by: Novartis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

179

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Collaborators

Novartis Vaccines

Investigators

  • Study Director: Drug Information Services, Chiron Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 3, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 13, 2007

Last Update Submitted That Met QC Criteria

March 12, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V48P2E3
  • 498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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