Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
This study has been completed.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00163618
  Purpose

The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.


Condition Intervention Phase
Encephalitis, Tick-Borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Phase IV

MedlinePlus related topics: Encephalitis
Drug Information available for: Immunoglobulins Globulin, Immune Sucrose Formaldehyde
U.S. FDA Resources
Study Type: Observational
Official Title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: June 2005
Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female children who participated in Study 146A if:
  • they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
  • written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians
  • they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
  • they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria:

  • Subjects who received any further TBE vaccination since their first TBE booster vaccination
  • Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
  • Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
  • Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
  • Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163618

Locations
Austria
Grieskirchner Strasse 17
Wels, Austria, 4600
Bahnhofstraße 9
Hermagor, Austria, 9620
Conrad-von-Hoetzendorf-Strasse
Voitsberg, Austria, 8570
Freistädter Strasse 290
Linz, Austria, 4040
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
  More Information

Study ID Numbers: 700501
Study First Received: September 8, 2005
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00163618  
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Baxter Healthcare Corporation:
tick-borne encephalitis

Study placed in the following topic categories:
Virus Diseases
Tick-borne encephalitis
Antibodies
Central Nervous System Infections
Formaldehyde
Central Nervous System Diseases
Arbovirus Infections
Brain Diseases
Tick-Borne Diseases
Encephalitis
Immunoglobulins
Encephalitis, Tick-Borne

Additional relevant MeSH terms:
Encephalitis, Viral
Anti-Infective Agents
Disinfectants
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Therapeutic Uses
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009