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