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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00452621 |
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Date of registration:
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26/03/2007 |
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Primary sponsor: |
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Public title:
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Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
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Scientific title:
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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 |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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235 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00452621 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Germany
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Contacts
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Name:
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Novartis Vaccines |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Encephalitis, Tick-Borne
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Intervention(s)
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Procedure: blood draw
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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(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
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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