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Trial record 9 of 35 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.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 8, 2005
Last updated: May 20, 2015
Last verified: May 2015
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 Pfizer:

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

Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00163618

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

Responsible Party: Pfizer Identifier: NCT00163618     History of Changes
Other Study ID Numbers: 700501
Study First Received: September 8, 2005
Last Updated: May 20, 2015

Keywords provided by Pfizer:
tick-borne encephalitis

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents processed this record on May 24, 2017