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FSME IMMUN NEW Follow-Up to Study 205 in Children Aged 6 to 16 Years
This study has been completed.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161889
  Purpose

The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all volunteers who completed two vaccinations in one of the three treatment groups of Baxter study 205 (safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy volunteers aged 6 to 16 years).


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Phase II

MedlinePlus related topics: Encephalitis
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Dose Comparison, Parallel Assignment
Official Title: Follow-Up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 6 to 16 Years

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 615
Study Start Date: February 2002
Estimated Study Completion Date: August 2002
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

All volunteers who participated in Baxter study 205 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

  • They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 205
  • They and/or their legal guardian understand the nature of the study, agree to its provisions and give written informed consent

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

  • Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)
  • Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 205
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 205
  • Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
  • Have received banked human blood or immunoglobulins within one month of study entry
  • Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 205
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 205
  • Had received an investigational new drug within 6 weeks prior to study start
  • If female and capable of bearing children – have a positive pregnancy test at the first medical examination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161889

Locations
Germany
Hauptstrasse 240
Kehl, Germany, D-77694
Neuschwanstein Strasse 5
Augsburg, Germany, D-86163
Hauptstrasse 11
Tegernsee, Germany, D-83681
Altoettinger Strasse 3
Landsberg, Germany, D-86899
Wilhelmstrasse 25
Metzingen, Germany, D-72555
Wilhelmstrasse 7
Offenburg, Germany, D-77654
Hauptstrasse 9
Bietigheim-Bissingen, Germany, D-74321
Solothumer Strasse 2
Heilbronn, Germany, D-74072
Dohmbuehler Strasse 8
Nuernberg, Germany, D-90449
Rastatter Strasse 7
Mannheim-Secken, Germany, 68239
Peter-Seifert Strasse 5
Gersfeld, Germany, D-36129
Rheinstrasse 1a
Ettenheim, Germany, D-77955
Schwarzwald Strasse 20
Kirchzarten, Germany, D-79199
Mohrenstrasse 8
Coburg, Germany, D-96450
Broner Platz 6
Weingarten, Germany, D-88250
Marktplatz 33
Bad Saulgau, Germany, D-88348
Berneckstrasse 19
Schramberg, Germany, D-78713
Bahnhofstrasse 1
Elzach, Germany, D-79215
Salzgasse 11
Calw, Germany, D-75365
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information

Study ID Numbers: 207
Study First Received: September 8, 2005
Last Updated: June 12, 2006
ClinicalTrials.gov Identifier: NCT00161889  
Health Authority: Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
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