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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00311441 |
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
Condition | Intervention | Phase |
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Encephalitis, Tick-Borne |
Biological: Tick-Borne Encephalitis vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules. |
Estimated Enrollment: | 300 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 1 Year to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | M48P3, 911 |
Study First Received: | April 3, 2006 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00311441 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
TBE, children, vaccine |
Virus Diseases Central Nervous System Infections Central Nervous System Diseases Healthy Arbovirus Infections |
Brain Diseases Tick-Borne Diseases Encephalitis Encephalitis, Tick-Borne |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Nervous System Diseases Central Nervous System Diseases Central Nervous System Viral Diseases Brain Diseases Encephalitis |
Tick-Borne Diseases Encephalitis, Tick-Borne Virus Diseases Encephalitis, Viral Central Nervous System Infections Arbovirus Infections Encephalitis, Arbovirus |