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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.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161798
First received: September 8, 2005
Last updated: June 12, 2006
Last verified: June 2006
  Purpose

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
  Eligibility

Ages Eligible for Study:   6 Years to 15 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161798

Locations
Germany
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
Investigators
Principal Investigator: Ulrich Behre, MD Hauptstrasse 240, 77694 Kehl, Germany
  More Information

No publications provided

ClinicalTrials.gov 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
Encephalitis, Tick-Borne
Arbovirus Infections
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Encephalitis, Viral
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
RNA Virus Infections
Tick-Borne Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014