Trial record 9 of 31 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:
Baxter Healthcare Corporation
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00163618
First received: September 8, 2005
Last updated: January 23, 2008
Last verified: January 2008
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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:
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 June 18, 2013