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
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
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

ClinicalTrials.gov processed this record on April 23, 2014