Trial record 9 of 32 for:    "Encephalitis, Tick-Borne"

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.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00163618
First received: September 8, 2005
Last updated: January 23, 2008
Last verified: January 2008
  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 4

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

Resource links provided by NLM:


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

No publications provided

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

Keywords provided by Baxter Healthcare Corporation:
tick-borne encephalitis

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
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
Formaldehyde
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014