An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE
Phase 4
Completed
- Conditions
- Tick Borne Encephalitis (TBE)
- Registration Number
- NCT01106482
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination 3 years after vaccination Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination 4 years after vaccination Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination 5 years after vaccination
- Secondary Outcome Measures
Name Time Method Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination 3 years after vaccination Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination 4 years after vaccination Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination 5 years after vaccination
Trial Locations
- Locations (10)
Winkelhoferstr. 3
🇩🇪Ehingen, Germany
Fuggerplatz 1
🇩🇪Kaufering, Germany
Hauptstrasse 240
🇩🇪Kehl, Germany
Bismarckstr. 3
🇩🇪Ludwigsburg, Germany
Am Marktplatz 8
🇩🇪Oberkirch, Germany
Großbottwarer Str. 47
🇩🇪Oberstenfeld, Germany
Wilhelmstr. 7
🇩🇪Offenburg, Germany
Stuttgarter Str. 74
🇩🇪Stuttgart, Germany
Martin-Niemöller-Str. 2
🇩🇪Traunreut, Germany
Murnauer Str. 3
🇩🇪Weilheim, Germany
Winkelhoferstr. 3🇩🇪Ehingen, Germany