Tick Borne Encephalitis (TBE) Clinical Trial
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
| Verified date | December 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institut |
| Study type | Interventional |
This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine
| Status | Completed |
| Enrollment | 126 |
| Est. completion date | May 2011 |
| Est. primary completion date | May 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 4 Years to 14 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Analysis of immunogenicity (TBE neutralizing antibody levels) 3 years after vaccination | 3 years after vaccination | No | |
| Primary | Analysis of immunogenicity (TBE neutralizing antibody levels) 4 years after vaccination | 4 years after vaccination | No | |
| Primary | Analysis of immunogenicity (TBE neutralizing antibody levels) 5 years after vaccination | 5 years after vaccination | No | |
| Secondary | Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 3 years after vaccination | 3 years after vaccination | No | |
| Secondary | Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 4 years after vaccination | 4 years after vaccination | No | |
| Secondary | Analysis of immunogenicity (TBE antibody levels as measured by ELISA) at 5 years after vaccination | 5 years after vaccination | No |