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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00161798
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
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Brief Summary:
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 or disease Intervention/treatment Phase
Tick-borne Encephalitis Biological: Tick-borne encephalitis vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : September 2001
Study Completion Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Wilhelmstrasse 7
Offenburg, Germany, 77654
Asternweg 11a
Offenburg, Germany, 77656
Bergstrasse 27
Rottweil, Germany, 78628
Berneckstrasse 19
Schrammberg, Germany, 78713
Hauptstrasse 11
Tegernsee, Germany, 83681
Broner Platz 6
Weingarten, Germany, 88250
Sponsors and Collaborators
Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany Identifier: NCT00161798     History of Changes
Other Study ID Numbers: 205
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections