search
Back to results

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

Primary Purpose

Tick Borne Encephalitis (TBE)

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Serology blood draw
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tick Borne Encephalitis (TBE) focused on measuring TBE, Tick Borne Encephalitis

Eligibility Criteria

4 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Winkelhoferstr. 3
  • Fuggerplatz 1
  • Hauptstrasse 240
  • Bismarckstr. 3
  • Am Marktplatz 8
  • Großbottwarer Str. 47
  • Wilhelmstr. 7
  • Stuttgarter Str. 74
  • Martin-Niemöller-Str. 2
  • Murnauer Str. 3

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination

Secondary Outcome Measures

Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination

Full Information

First Posted
April 12, 2010
Last Updated
December 7, 2011
Sponsor
Novartis Vaccines
search

1. Study Identification

Unique Protocol Identification Number
NCT01106482
Brief Title
An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick Borne Encephalitis (TBE)
Keywords
TBE, Tick Borne Encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Title
Arm 4
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Serology blood draw
Intervention Description
Blood draw only, no vaccine
Primary Outcome Measure Information:
Title
Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination
Time Frame
3 years after vaccination
Title
Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination
Time Frame
4 years after vaccination
Title
Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination
Time Frame
5 years after vaccination
Secondary Outcome Measure Information:
Title
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination
Time Frame
3 years after vaccination
Title
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination
Time Frame
4 years after vaccination
Title
Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination
Time Frame
5 years after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Winkelhoferstr. 3
City
Ehingen
ZIP/Postal Code
89584
Country
Germany
Facility Name
Fuggerplatz 1
City
Kaufering
ZIP/Postal Code
86916
Country
Germany
Facility Name
Hauptstrasse 240
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Bismarckstr. 3
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Am Marktplatz 8
City
Oberkirch
ZIP/Postal Code
77704
Country
Germany
Facility Name
Großbottwarer Str. 47
City
Oberstenfeld
ZIP/Postal Code
71720
Country
Germany
Facility Name
Wilhelmstr. 7
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Stuttgarter Str. 74
City
Stuttgart
ZIP/Postal Code
70469
Country
Germany
Facility Name
Martin-Niemöller-Str. 2
City
Traunreut
ZIP/Postal Code
83301
Country
Germany
Facility Name
Murnauer Str. 3
City
Weilheim
ZIP/Postal Code
82362
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25728316
Citation
Wittermann C, Izu A, Petri E, Gniel D, Fragapane E. Five year follow-up after primary vaccination against tick-borne encephalitis in children. Vaccine. 2015 Apr 8;33(15):1824-9. doi: 10.1016/j.vaccine.2015.02.038. Epub 2015 Feb 26.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs