Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00452621
First received: March 26, 2007
Last updated: April 22, 2008
Last verified: April 2008
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Purpose
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
| Condition | Intervention | Phase |
|---|---|---|
|
Encephalitis, Tick-Borne |
Procedure: blood draw |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage
Secondary Outcome Measures:
- (2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce
| Estimated Enrollment: | 235 |
| Study Start Date: | February 2007 |
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452621
Locations
| Germany | |
| Center 7 | |
| Aschaffenburg, Germany, 63741 | |
| Center 2 | |
| Bobingen, Germany, 86399 | |
| Center 11 | |
| Eberbach /Neckar, Germany, 69412 | |
| Center 4 | |
| Kaufering, Germany, 86916 | |
| Center 15 | |
| Pegnitz, Germany, 91257 | |
| Center 1 | |
| Weilheim i. OB, Germany, 82362 | |
| Center 8 | |
| Wiesloch, Germany, 69168 | |
| Center 16 | |
| Zirndorf, Germany, 90513 | |
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00452621 History of Changes |
| Other Study ID Numbers: | V48P4E3 |
| Study First Received: | March 26, 2007 |
| Last Updated: | April 22, 2008 |
| Health Authority: | Germany:Paul-Ehrlich-Institute |
Keywords provided by Novartis:
|
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children TBE |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Tick-Borne Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections |
Encephalitis, Arbovirus Arbovirus Infections Tick-Borne Diseases Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 18, 2013