An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

December 7, 2011 updated by: Novartis Vaccines

A Phase IV, Open-label, Multi-center Follow-up Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

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

  • Germany
      • Ehingen, Germany, 89584
        • Winkelhoferstr. 3
      • Kaufering, Germany, 86916
        • Fuggerplatz 1
      • Kehl, Germany, 77694
        • Hauptstrasse 240
      • Ludwigsburg, Germany, 71634
        • Bismarckstr. 3
      • Oberkirch, Germany, 77704
        • Am Marktplatz 8
      • Oberstenfeld, Germany, 71720
        • Großbottwarer Str. 47
      • Offenburg, Germany, 77654
        • Wilhelmstr. 7
      • Stuttgart, Germany, 70469
        • Stuttgarter Str. 74
      • Traunreut, Germany, 83301
        • Martin-Niemöller-Str. 2
      • Weilheim, Germany, 82362
        • Murnauer Str. 3

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

4 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion Criteria:

  • Subjects who did not receive complete schedule of primary vaccination in the parent study
  • Subjects enrolled in other investigational studies at the same time and within the last three months
  • Subjects with any condition which, 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 1
Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 3
Other: Serology blood draw
Blood draw only, no vaccine
Active Comparator: Arm 4
Other: Serology blood draw
Blood draw only, no vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Time Frame: 3 years after vaccination
3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Time Frame: 4 years after vaccination
4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
Time Frame: 5 years after vaccination
5 years after vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Time Frame: 3 years after vaccination
3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Time Frame: 4 years after vaccination
4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
Time Frame: 5 years after vaccination
5 years after vaccination

Collaborators and Investigators

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

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 19, 2010

First Posted (Estimate)

April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

December 8, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M48P3E1

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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