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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

Primary Purpose

Encephalitis, Tick-borne

Status
Completed
Phase
Locations
Austria
Study Type
Observational
Intervention
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Encephalitis, Tick-borne focused on measuring tick-borne encephalitis

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bahnhofstraße 9
  • Freistädter Strasse 290
  • Conrad-von-Hoetzendorf-Strasse
  • Grieskirchner Strasse 17

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00163618
Brief Title
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
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
Study Type
Observational

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-borne
Keywords
tick-borne encephalitis

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter BioScience Investigator
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bahnhofstraße 9
City
Hermagor
ZIP/Postal Code
9620
Country
Austria
Facility Name
Freistädter Strasse 290
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
Conrad-von-Hoetzendorf-Strasse
City
Voitsberg
ZIP/Postal Code
8570
Country
Austria
Facility Name
Grieskirchner Strasse 17
City
Wels
ZIP/Postal Code
4600
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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