Japanese Encephalitis |
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Clinical Trial: Dose-Finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations with FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
This study has been completed.
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Tick-Borne Encephalitis | Vaccine: Tick-borne Encephalitis Vaccine | Phase II |
MedlinePlus related topics: Encephalitis; Tick Bites; Viral Infections
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment
Official Title: Double-Blind, Randomized, Multicenter Dose-Finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations with FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
Study start: March 2002; Study completion: August 2002
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
Male and female children will be eligible for participation in this study if:
- they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old;
- they are clinically healthy;
- their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
Exclusion Criteria:
Children will be excluded from participation in this study if they:
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the vaccine;
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions;
- suffer from chronic, degenerative and / or inflammatory disease of the central nervous system;
- are known to be HIV positive (a special HIV test is not required for the purpose of the study);
- suffer from a febrile illness at study entry;
- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- are participating simultaneously in another clinical trial.
Location Information
Germany
Hauptstraße 240, Kehl, D-77694, Germany
Baxter BioScience Investigator, Principal Investigator, Baxter BioScience
More Information
Last Updated: September 12, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00161772
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Japanese Encephalitis (Centers for Disease Control and Prevention)

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