Dose-Finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

This study has been completed.
Information provided by:
Baxter Healthcare Corporation Identifier:
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006

The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years.

Condition Intervention Phase
Tick-Borne Encephalitis
Biological: Tick-borne encephalitis vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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 6 to 16 Years.

Resource links provided by NLM:

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: September 2001
Estimated Study Completion Date: March 2002

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Male and female children will be eligible for participation in this study if:

  • they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
  • they are clinically healthy;
  • their legal representative – and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
  • their legal representative agrees to keep a Volunteer Diary.

For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:

  • negative pregnancy test at study start;
  • they agree to employ adequate birth control measures for the duration of the study.

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.
  • if female, are pregnant or breast feeding

Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.

  Contacts and Locations
Please refer to this study by its identifier: NCT00161798

Neuschwansteinstrasse 5
Augsburg, Germany, 86163
Marktplatz 33
Bad Saulgau, Germany, 88348
Hauptstrasse 9
Bietigheim-Bissingen, Germany, 74321
Salzgasse 11
Calw, Germany, 75365
Mohrenstrasse 8
Coburg, Germany, 96450
Bahnhofstrasse 1
Elzach, Germany, 79215
Rheinstrasse 13
Ettenheim, Germany, 77955
Peter-Seifert Strasse 5
Gersfeld, Germany, 36129
Solothurner Strasse 2
Heilbronn, Germany, 74072
Hauptstraße 240
Kehl, Germany, 77694
Schwarzwaldstrasse 20
Kirchzarten, Germany, 79199
Altoettingerstrasse 3
Landsberg, Germany, 86899
Rastatter Strasse 7
Mannheim-Secken, Germany, 68239
Wilhelmstrasse 25
Metzingen, Germany, 72555
Heubischer Strasse 39
Neustadt/Cbg, Germany, 96465
Dohmbuehlerstrasse 8
Nürnberg, Germany, 90449
Schwarzwaldstrasse 18
Oberkirch, Germany, 77704
Asternweg 11a
Offenburg, Germany, 77656
Wilhelmstrasse 7
Offenburg, Germany, 77654
Bergstrasse 27
Rottweil, Germany, 78628
Berneckstrasse 19
Schrammberg, Germany, 78713
Hauptstrasse 11
Tegernsee, Germany, 83681
Broner Platz 6
Weingarten, Germany, 88250
Sponsors and Collaborators
Baxter Healthcare Corporation
Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
  More Information

No publications provided Identifier: NCT00161798     History of Changes
Other Study ID Numbers: 205
Study First Received: September 8, 2005
Last Updated: June 12, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
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 processed this record on April 17, 2014