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FSME IMMUN NEW Follow-Up to Study 199 in Children Aged 1 to 6 Years

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00161850
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 the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 1 to 6 Years

Resource links provided by NLM:


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:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All volunteers who participated in Baxter study 199 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 199
  • Written informed consent from the legal guardian is available.

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 199
  • Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199
  • 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 199
  • Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199
  • Had received an investigational new drug within 6 weeks prior to study start
  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: NCT00161850

Locations
Austria
Grieskirchner Strasse 17
Wels, Austria, A-4600
Germany
Neuschwanstein Strasse 5
Augsburg, Germany, D-86163
Marktplatz 33
Bad Saulgau, Germany, D-88348
Hauptstrasse 9
Bietigheim-Bissingen, Germany, D-74321
Salzgasse 11
Calw, Germany, D-75365
Mohrenstrasse 8
Coburg, Germany, D-96450
Bahnhofstrasse 1
Elzach, Germany, D-79215
Rheinstrasse 1a
Ettenheim, Germany, D-77955
Ehlerstrasse 17
Friedrichshafen, Germany, D-88046
Peter-Seifert Strasse 5
Gersfeld, Germany, D-36129
Solothumer Strasse 2
Heilbronn, Germany, D-74072
Hauptstrasse 240
Kehl, Germany, D-77694
Schwarzwald Strasse 20
Kirchzarten, Germany, D-79199
Altoettinger Strasse 3
Landsberg, Germany, D-86899
Rastatter Strasse 7
Mannheim-Secken, Germany, 68239
Wilhelmstrasse 25
Metzingen, Germany, D-72555
Dohmbuehler Strasse 8
Nuernberg, Germany, D-90449
Glogauer Strasse 15
Nuernberg, Germany, D-90473
Tuchbergstrasse 2
Oberndorf/Neckar, Germany, D-78727
Asternweg 11a
Offenburg, Germany, D-77656
Wilhelmstrasse 7
Offenburg, Germany, D-77654
Bergstrasse 27
Rottweil, Germany, D-78628
Berneckstrasse 19
Schramberg, Germany, D-78713
Hauptstrasse 11
Tegernsee, Germany, D-83681
Broner Platz 6
Weingarten, Germany, D-88250
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161850     History of Changes
Other Study ID Numbers: 206
Study First Received: September 8, 2005
Last Updated: June 12, 2006
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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 20, 2014