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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.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161772
  Purpose

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.


Condition Intervention Phase
Tick-Borne Encephalitis
Biological: Tick-borne Encephalitis Vaccine
Phase II

MedlinePlus related topics: Encephalitis
U.S. FDA Resources
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.

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: March 2002
Estimated Study Completion Date: August 2002
  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161772

Locations
Austria
Grieskirchner Strasse 17
Wels, Austria, 4600
Germany
Hauptstraße 240
Kehl, Germany, 77694
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
Solothurner Strasse 2
Heilbronn, Germany, 74072
Rheinstrasse 13
Ettenheim, Germany, 77955
Broner Platz 6
Weingarten, Germany, 88250
Marktplatz 3
Bad Saulgau, Germany, 88348
Berneckstrasse 19
Schrammberg, Germany, 78713
Tuchbergstrasse 2
Oberndorf / Neckar, Germany, 78727
Asternweg 11a
Offenburg, Germany, 77656
Hauptstrasse 9
Bietigheim-Bissingen, Germany, 74321
Rastatter Strasse 7
Mannheim-Secken, Germany, 68239
Altoettingerstrasse 3
Landsberg, Germany, 86899
Glogauer Strasse 15
Nürnberg, Germany, 90473
Wilhelmstrasse 7
Offenburg, Germany, 77654
Heubischer Strasse 39
Neustadt/Cbg, Germany, 96465
Dohmbuehlerstrasse 8
Nürnberg, Germany, 90449
Salzgasse 11
Calw, Germany, 75365
Peter-Seifert-Strasse 5
Gersfeld, Germany, 36129
Schwarzwaldstrasse 20
Kirchzarten, Germany, 79199
Mohrenstrasse 8
Coburg, Germany, 96450
Bahnhofstrasse 1
Elzach, Germany, 79215
Hauptstrasse 11
Tegernsee, Germany, 83681
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
  More Information

Study ID Numbers: 199
Study First Received: September 8, 2005
Last Updated: June 12, 2006
ClinicalTrials.gov Identifier: NCT00161772  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Virus Diseases
Tick-borne encephalitis
Signs and Symptoms
Central Nervous System Infections
Central Nervous System Diseases
Healthy
Arbovirus Infections
Brain Diseases
Tick-Borne Diseases
Encephalitis
Encephalitis, Tick-Borne

Additional relevant MeSH terms:
Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009